Device Classification Name |
Tape And Bandage, Adhesive
|
510(k) Number |
K901845 |
Device Name |
TEGADERM BRAND TRANSPARENT DRESSING SERIES 16XX |
Applicant |
3M COMPANY |
CHEMOLITE BLVD. & WASHINGTON |
CITY RD. 19 |
COTTAE GROVE,
MN
55016
|
|
Applicant Contact |
CHARLES W OPP |
Correspondent |
3M COMPANY |
CHEMOLITE BLVD. & WASHINGTON |
CITY RD. 19 |
COTTAE GROVE,
MN
55016
|
|
Correspondent Contact |
CHARLES W OPP |
Regulation Number | 880.5240
|
Classification Product Code |
|
Date Received | 04/24/1990 |
Decision Date | 07/23/1990 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|