The following data is part of a premarket notification filed by Intl. Medical Marketing, Inc. with the FDA for L.t.c. 1000 Urinary Drainage Bag.
| Device ID | K895957 |
| 510k Number | K895957 |
| Device Name: | L.T.C. 1000 URINARY DRAINAGE BAG |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| Applicant | INTL. MEDICAL MARKETING, INC. P.O. BOX 578 Ridge, NY 11961 |
| Contact | Ramon Monast |
| Correspondent | Ramon Monast INTL. MEDICAL MARKETING, INC. P.O. BOX 578 Ridge, NY 11961 |
| Product Code | KNX |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-11 |
| Decision Date | 1989-10-24 |