Surgi-Tag(Tm) Sterile Label Sets
FDA 510(k) K884055 · Acacia Laboratories, Inc.
510(k) numberK884055
Submission
- Device name
- Surgi-Tag(Tm) Sterile Label Sets
- Applicant
- Acacia Laboratories, Inc.
Santa Ana, CA, US - Received
- September 26, 1988
- Decision date
- October 13, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LYV – Label Or Tag, Sterile
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code LYV
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K883654 | Steri-Tag(Tm) Sterile Label SetsLYV · Traditional | Acacia Laboratories, Inc. | 10/13/1988SE |
More from Acacia Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K952419 | Sterigauze Gel DressingMGQ · Traditional | 07/26/1995SE |
| K952420 | Sterigauze Wet DressingKMF · Traditional | 07/12/1995SE |
| K951861 | Stericare Wound Care GelMGQ · Traditional | 07/11/1995SE |
| K952414 | Prefilled Syringe for Inflation of Foley CatheterKNY · Traditional | 06/23/1995SE |
| K951914 | Hydracare Absorbent Wound DressingKMF · Traditional | 05/15/1995SN |
| K950344 | Horizon Foley Catheterization Tray Without CatheterFCM · Traditional | 03/24/1995SEKD |
| K913408 | Sterile Plastic DrapeKKX · Traditional | 03/12/1992SE |
| K901761 | Sterile Suction Tubing SetBYY · Traditional | 05/07/1990SE |
| K892856 | Newmark(Tm) Coronary Artery Bypass Graft MarkersKRI · Traditional | 11/08/1989SE |
| K892804 | Newchill(Tm) Cardiac InsulatorDWS · Traditional | 07/14/1989SE |
Questions and answers
When was Surgi-Tag(Tm) Sterile Label Sets cleared by the FDA?
Surgi-Tag(Tm) Sterile Label Sets (K884055) received a 510(k) decision of Substantially Equivalent on October 13, 1988, 17 days after the submission was received.
What is the product code of K884055?
The FDA product code is LYV – Label Or Tag, Sterile, a Class I (low risk) device regulated under 21 CFR 878.4800.