The following data is part of a premarket notification filed by Mark One Healthcare Products with the FDA for Parema K Band Non-sterile.
| Device ID | K833867 |
| 510k Number | K833867 |
| Device Name: | PAREMA K BAND NON-STERILE |
| Classification | Gauze/sponge, Internal |
| Applicant | MARK ONE HEALTHCARE PRODUCTS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EFQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-07 |
| Decision Date | 1984-01-27 |