The following data is part of a premarket notification filed by 3m Health Care with the FDA for 3m Tegaderm Transparent Dressing, 3m Tegaderm Transparent Dressing (first Aid Delivery), 3m Tegaderm Hp Transparent Dres.
Device ID | K973036 |
510k Number | K973036 |
Device Name: | 3M TEGADERM TRANSPARENT DRESSING, 3M TEGADERM TRANSPARENT DRESSING (FIRST AID DELIVERY), 3M TEGADERM HP TRANSPARENT DRES |
Classification | Dressing, Wound And Burn, Occlusive |
Applicant | 3M HEALTH CARE P.O. BOX 33275 3M CENTER, 275-3E-08 St. Paul, MN 55144 -1000 |
Contact | Karen C Holmen |
Correspondent | Karen C Holmen 3M HEALTH CARE P.O. BOX 33275 3M CENTER, 275-3E-08 St. Paul, MN 55144 -1000 |
Product Code | MGP |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-08-14 |
Decision Date | 1997-11-12 |
Summary: | summary |