The following data is part of a premarket notification filed by 3m Health Care, Ltd. with the FDA for 3m Water Dispersible Adhesive Tape, 98xx.
Device ID | K912520 |
510k Number | K912520 |
Device Name: | 3M WATER DISPERSIBLE ADHESIVE TAPE, 98XX |
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 | Hirte |
Correspondent | Hirte 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 | 1991-06-06 |
Decision Date | 1991-07-26 |