The following data is part of a premarket notification filed by Specialty Medical Products Co. with the FDA for Basic Dressing Change Tray Smp 102a.
| Device ID | K922845 |
| 510k Number | K922845 |
| Device Name: | BASIC DRESSING CHANGE TRAY SMP 102A |
| Classification | Wrap, Sterilization |
| Applicant | SPECIALTY MEDICAL PRODUCTS CO. 1604 MERRILL DR. SUITE D Little Rock, AR 72212 |
| Contact | John Lamb |
| Correspondent | John Lamb SPECIALTY MEDICAL PRODUCTS CO. 1604 MERRILL DR. SUITE D Little Rock, AR 72212 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-12 |
| Decision Date | 1992-12-29 |