The following data is part of a premarket notification filed by James River Corp. with the FDA for Visulin Transparent Adhesive Dressing.
Device ID | K894147 |
510k Number | K894147 |
Device Name: | VISULIN TRANSPARENT ADHESIVE DRESSING |
Classification | Tape And Bandage, Adhesive |
Applicant | JAMES RIVER CORP. 1915 MARATHON AVE. Neenah, WI 54956 |
Contact | Richard Davis |
Correspondent | Richard Davis JAMES RIVER CORP. 1915 MARATHON AVE. Neenah, WI 54956 |
Product Code | KGX |
CFR Regulation Number | 880.5240 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-06-14 |
Decision Date | 1989-08-09 |