The following data is part of a premarket notification filed by Reed Products, Inc. with the FDA for First Response Emerg. Medicsl - Burns.
| Device ID | K841898 |
| 510k Number | K841898 |
| Device Name: | FIRST RESPONSE EMERG. MEDICSL - BURNS |
| Classification | Sheet, Burn |
| Applicant | REED PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FPY |
| CFR Regulation Number | 880.5180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-07 |
| Decision Date | 1984-08-14 |