The following data is part of a premarket notification filed by 3m Health Care, Ltd. with the FDA for 3m Tegaderm Hp Transparent Dressing.
Device ID | K932422 |
510k Number | K932422 |
Device Name: | 3M TEGADERM HP TRANSPARENT DRESSING |
Classification | Tape And Bandage, Adhesive |
Applicant | 3M HEALTH CARE, LTD. 3M CENTER, BLDG. 275-3E-08 P.O. BOX 33275 St. Paul, MN 55133 |
Contact | Suzanne M Danielson |
Correspondent | Suzanne M Danielson 3M HEALTH CARE, LTD. 3M CENTER, BLDG. 275-3E-08 P.O. BOX 33275 St. Paul, MN 55133 |
Product Code | KGX |
CFR Regulation Number | 880.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-19 |
Decision Date | 1993-12-27 |