The following data is part of a premarket notification filed by Kay Medical Concepts with the FDA for Kit, Surgical Instrument, Disposable.
| Device ID | K925905 |
| 510k Number | K925905 |
| Device Name: | KIT, SURGICAL INSTRUMENT, DISPOSABLE |
| Classification | Kit, Surgical Instrument, Disposable |
| Applicant | KAY MEDICAL CONCEPTS 3280-E PEACHTREE CORNERS CIRCL Norcross, GA 30092 |
| Contact | Kevin Coughlin |
| Correspondent | Kevin Coughlin KAY MEDICAL CONCEPTS 3280-E PEACHTREE CORNERS CIRCL Norcross, GA 30092 |
| Product Code | KDD |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-18 |
| Decision Date | 1993-06-16 |