The following data is part of a premarket notification filed by Coloplast Corp. with the FDA for Comfeel Seasorb Dressing.
| Device ID | K983519 |
| 510k Number | K983519 |
| Device Name: | COMFEEL SEASORB DRESSING |
| Classification | Bandage, Liquid |
| Applicant | COLOPLAST CORP. 1955 WEST OAK CIR. Marietta, GA 30062 -2249 |
| Contact | M.sydney Lilly |
| Correspondent | M.sydney Lilly COLOPLAST CORP. 1955 WEST OAK CIR. Marietta, GA 30062 -2249 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-08 |
| Decision Date | 1998-12-30 |
| Summary: | summary |