The following data is part of a premarket notification filed by Biocor Medical, Inc. with the FDA for Angiography Drape Pack.
Device ID | K902293 |
510k Number | K902293 |
Device Name: | ANGIOGRAPHY DRAPE PACK |
Classification | General Surgery Tray |
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 | LRO |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent - With Drug (SESD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-05-22 |
Decision Date | 1990-07-19 |