The following data is part of a premarket notification filed by American Medical Products, Inc. with the FDA for Amp Closed Urinary Drainage Bag, 1011 & 1011n.
| Device ID | K861251 |
| 510k Number | K861251 |
| Device Name: | AMP CLOSED URINARY DRAINAGE BAG, 1011 & 1011N |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| Applicant | AMERICAN MEDICAL PRODUCTS, INC. 759 NORTH EDGEWOOD AVE. Jacksonville, FL 32205 |
| Contact | Keith E Welss |
| Correspondent | Keith E Welss AMERICAN MEDICAL PRODUCTS, INC. 759 NORTH EDGEWOOD AVE. Jacksonville, FL 32205 |
| Product Code | KNX |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-02 |
| Decision Date | 1986-04-17 |