The following data is part of a premarket notification filed by Biocor, Inc. with the FDA for Weight Bag.
Device ID | K941592 |
510k Number | K941592 |
Device Name: | WEIGHT BAG |
Classification | System, X-ray, Stationary |
Applicant | BIOCOR, INC. 1530 SOUTH SOUTHWEST LOOP 323 SUITE 200 Tyler, TX 75701 |
Contact | Don M Walden |
Correspondent | Don M Walden BIOCOR, INC. 1530 SOUTH SOUTHWEST LOOP 323 SUITE 200 Tyler, TX 75701 |
Product Code | KPR |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-03-31 |
Decision Date | 1994-06-06 |