The following data is part of a premarket notification filed by Biocor Medical, Inc. with the FDA for Surgical Drape.
| Device ID | K910084 |
| 510k Number | K910084 |
| Device Name: | SURGICAL DRAPE |
| Classification | Drape, Surgical |
| Applicant | BIOCOR MEDICAL, INC. 1008 NCNB CENTER 102 NORTH COLLEGE Tyler, TX 75702 |
| Contact | Mickey Fowler |
| Correspondent | Mickey Fowler BIOCOR MEDICAL, INC. 1008 NCNB CENTER 102 NORTH COLLEGE Tyler, TX 75702 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-08 |
| Decision Date | 1991-03-19 |