The following data is part of a premarket notification filed by Parema Ltd. with the FDA for K-band And K-crepe.
| Device ID | K926072 |
| 510k Number | K926072 |
| Device Name: | K-BAND AND K-CREPE |
| Classification | Gauze / Sponge,nonresorbable For External Use |
| Applicant | PAREMA LTD. SULLINGTON ROAD Shepshed, Loughborough, Leics., GB Le12 9jj |
| Contact | Stephen Kattan |
| Correspondent | Stephen Kattan PAREMA LTD. SULLINGTON ROAD Shepshed, Loughborough, Leics., GB Le12 9jj |
| Product Code | NAB |
| CFR Regulation Number | 878.4014 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-01 |
| Decision Date | 1993-03-19 |