The following data is part of a premarket notification filed by Bio-vascular, Inc. with the FDA for Insulation Pad.
| Device ID | K896307 |
| 510k Number | K896307 |
| Device Name: | INSULATION PAD |
| Classification | Instruments, Surgical, Cardiovascular |
| Applicant | BIO-VASCULAR, INC. 2670 PATTON RD. Saint Paul, MN 55113 |
| Contact | Sherry Krattley |
| Correspondent | Sherry Krattley BIO-VASCULAR, INC. 2670 PATTON RD. Saint Paul, MN 55113 |
| Product Code | DWS |
| CFR Regulation Number | 870.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-31 |
| Decision Date | 1990-01-19 |