The following data is part of a premarket notification filed by Baka Manufacturing Co., Inc. with the FDA for Catheter Strap & Ruinary Bay Holder.
| Device ID | K780190 |
| 510k Number | K780190 |
| Device Name: | CATHETER STRAP & RUINARY BAY HOLDER |
| Classification | Bag, Urine Collection, Leg, For External Use, Sterile |
| Applicant | BAKA MANUFACTURING CO., INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FAQ |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-02-06 |
| Decision Date | 1978-02-21 |