The following data is part of a premarket notification filed by John F. Greer Co., Inc. with the FDA for E-z Loop.
Device ID | K870577 |
510k Number | K870577 |
Device Name: | E-Z LOOP |
Classification | Collector, Ostomy |
Applicant | JOHN F. GREER CO., INC. 530 E. 12TH ST. Oakland, CA 94606 |
Contact | L. H Greer |
Correspondent | L. H Greer JOHN F. GREER CO., INC. 530 E. 12TH ST. Oakland, CA 94606 |
Product Code | EXB |
CFR Regulation Number | 876.5900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-02-10 |
Decision Date | 1987-04-17 |