The following data is part of a premarket notification filed by Martell Medical Products, Inc. with the FDA for A-liner.
| Device ID | K821096 |
| 510k Number | K821096 |
| Device Name: | A-LINER |
| Classification | Syringe, Piston |
| Applicant | MARTELL MEDICAL PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-04-20 |
| Decision Date | 1982-05-14 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() A-LINER 73762300 1548151 Dead/Cancelled |
SHERWOOD MEDICAL COMPANY 1988-11-07 |