The following data is part of a premarket notification filed by Advanced Clinical Products, Inc. with the FDA for Gentle Back, Plastic Urinary Drainage Bag.
| Device ID | K861192 |
| 510k Number | K861192 |
| Device Name: | GENTLE BACK, PLASTIC URINARY DRAINAGE BAG |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| Applicant | ADVANCED CLINICAL PRODUCTS, INC. P.O. BOX 35684 Richmond, VA 23235 |
| Contact | Gene L Mrava |
| Correspondent | Gene L Mrava ADVANCED CLINICAL PRODUCTS, INC. P.O. BOX 35684 Richmond, VA 23235 |
| Product Code | KNX |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-31 |
| Decision Date | 1986-04-23 |