The following data is part of a premarket notification filed by 3m Health Care, Ltd. with the FDA for 3m Incontinence Barrier Film, Product Series 336x.
| Device ID | K930468 |
| 510k Number | K930468 |
| Device Name: | 3M INCONTINENCE BARRIER FILM, PRODUCT SERIES 336X |
| Classification | Bandage, Liquid |
| 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 | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-28 |
| Decision Date | 1993-08-06 |