The following data is part of a premarket notification filed by Coloplast Corp. with the FDA for Compeed Psoriasis Dressing.
Device ID | K982493 |
510k Number | K982493 |
Device Name: | COMPEED PSORIASIS DRESSING |
Classification | Dressing, Wound And Burn, Occlusive |
Applicant | COLOPLAST CORP. 1955 WEST OAK CIR. Marietta, GA 30062 -2249 |
Contact | Sydney Lilly |
Correspondent | Sydney Lilly COLOPLAST CORP. 1955 WEST OAK CIR. Marietta, GA 30062 -2249 |
Product Code | MGP |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-07-17 |
Decision Date | 1999-01-28 |
Summary: | summary |