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 |