The following data is part of a premarket notification filed by Vlv Associates, Inc. with the FDA for Hold-it Framed Adhesive Film.
| Device ID | K860071 |
| 510k Number | K860071 |
| Device Name: | HOLD-IT FRAMED ADHESIVE FILM |
| Classification | Device, Intravascular Catheter Securement |
| Applicant | VLV ASSOCIATES, INC. 30 RIDGEDALE AVE. East Hanover, NJ 07936 |
| Contact | V. L Vaillancourt |
| Correspondent | V. L Vaillancourt VLV ASSOCIATES, INC. 30 RIDGEDALE AVE. East Hanover, NJ 07936 |
| Product Code | KMK |
| CFR Regulation Number | 880.5210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-06 |
| Decision Date | 1986-01-27 |