The following data is part of a premarket notification filed by Lifemed Of California with the FDA for Lifecoil Catheter.
Device ID | K903502 |
510k Number | K903502 |
Device Name: | LIFECOIL CATHETER |
Classification | Catheter, Peritoneal, Long-term Indwelling |
Applicant | LIFEMED OF CALIFORNIA 2059 DEL AMO BLVD. Compton, CA 90220 |
Contact | Patricia Brinker |
Correspondent | Patricia Brinker LIFEMED OF CALIFORNIA 2059 DEL AMO BLVD. Compton, CA 90220 |
Product Code | FJS |
CFR Regulation Number | 876.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-08-03 |
Decision Date | 1990-10-22 |