Shield Lucky Cap; Blossom Bouffant Cap
FDA 510(k) K800511 · American Convertors Div., American Pharmaseal
510(k) numberK800511
Submission
- Device name
- Shield Lucky Cap; Blossom Bouffant Cap
- Applicant
- American Convertors Div., American Pharmaseal
Mchenry, IL, US - Received
- March 5, 1980
- Decision date
- April 16, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FYF – Cap, Surgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4040
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FYF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972227 | Shoe CoverFYF · Traditional | American Seal Co. | 09/09/1997SE |
| K955833 | Niomed Surgical CapsFYF · Traditional | Amerasia Corp. | 03/15/1996SE |
| K954556 | Surgical CapFYF · Traditional | Thai Disposable Products Co., Ltd. | 03/12/1996SE |
| K954455 | Niomed Bouffant CapsFYF · Traditional | Amerasia Corp. | 01/23/1996SE |
| K954454 | Niomed Surgical HoodFYF · Traditional | Amerasia Corp. | 01/23/1996SE |
| K953879 | Surgeon's CapFYF · Traditional | American Threshold Industries, Inc. | 01/05/1996SE |
| K953878 | Bouffant CapFYF · Traditional | American Threshold Industries, Inc. | 01/05/1996SE |
| K913700 | Disposable Bouffant CapFYF · Traditional | Gem Nonwovews, Inc. | 10/04/1991SE |
| K882346 | Instrument Protect-A-Caps, Aka: Tip/Instru. GuardFYF · Traditional | Nordbye, Milchman, Barlage | 06/30/1988SE |
| K882284 | Surgeons CapFYF · Traditional | A Plus International, Inc. | 06/23/1988SE |
More from A Plus International, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K840957 | Antimicrobial Incise DrapeKKX · Traditional | 06/07/1984SE |
| K832137 | Convertors Flash Sterilizing TrayFSM · Traditional | 08/12/1983SE |
| K830786 | Disimetric Release of Instranetics RadKOA · Traditional | 05/18/1983SE |
| K820994 | Absorb Furn SheetFPY · Traditional | 05/13/1982SE |
| K813419 | Comfort Cushion Dry Burn Pad IIINAB · Traditional | 01/22/1982SE |
| K813296 | Convertors Sterile Disp. Lap Sponge IIEFQ · Traditional | 12/29/1981SE |
| K813078 | Contura Dispos. Surg. Face MaskFXX · Traditional | 12/18/1981SE |
| K812554 | Tomac Sterile Disp. Lap SpongeGDY · Traditional | 09/24/1981SE |
| K802919 | Iso-Bac Instrument WrapFRG · Traditional | 02/02/1981SE |
| K802998 | Patient Care Disposable Infant ShirtsKME · Traditional | 12/22/1980SE |
Questions and answers
When was Shield Lucky Cap; Blossom Bouffant Cap cleared by the FDA?
Shield Lucky Cap; Blossom Bouffant Cap (K800511) received a 510(k) decision of Substantially Equivalent on April 16, 1980, 42 days after the submission was received.
What is the product code of K800511?
The FDA product code is FYF – Cap, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4040.