The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Comfeel Transparent Dressing.
| Device ID | K894916 |
| 510k Number | K894916 |
| Device Name: | COMFEEL TRANSPARENT DRESSING |
| Classification | Tape And Bandage, Adhesive |
| Applicant | COLOPLAST A/S C/O RICHARD HAMER ASSOC., INC. P.O. BOX 16598 Ft. Worth, TX 76162 |
| Contact | Richard Hamer |
| Correspondent | Richard Hamer COLOPLAST A/S C/O RICHARD HAMER ASSOC., INC. P.O. BOX 16598 Ft. Worth, TX 76162 |
| Product Code | KGX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-02 |
| Decision Date | 1989-09-26 |