Surgical Cap Calot
FDA 510(k) K851558 · Roseburg SA
510(k) numberK851558
Submission
- Device name
- Surgical Cap Calot
- Applicant
- Roseburg SA
Washington, DC, US - Received
- April 16, 1985
- Decision date
- April 30, 1985
- 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 |
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| K885275 | Assenat-Bleschet SunglassesHQY · Traditional | 01/24/1989SE |
| K882392 | Burnet Laboratoire Pharmaceutique Surgical GlovesKGO · Traditional | 08/26/1988SE |
| K872715 | Universal Instrumentation(Cd) for Spinal SurgeryJDN · Traditional | 12/07/1987SN |
| K874317 | Poirier Kid-Roller Manual WheelchairIOR · Traditional | 11/17/1987SE |
| K872714 | S.T.A.C.E.M. External Breast Prosthesis MammaryGBI · Traditional | 07/21/1987SE |
| K871689 | Spectacle Frame - LorraineHQZ · Traditional | 05/29/1987SE |
| K871688 | Spectacle Frame - DanielleHQZ · Traditional | 05/29/1987SE |
| K870654 | Efer ArthroscopeHRX · Traditional | 05/14/1987SE |
Questions and answers
When was Surgical Cap Calot cleared by the FDA?
Surgical Cap Calot (K851558) received a 510(k) decision of Substantially Equivalent on April 30, 1985, 14 days after the submission was received.
What is the product code of K851558?
The FDA product code is FYF – Cap, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4040.