The following data is part of a premarket notification filed by John F. Greer Co., Inc. with the FDA for E-z Hold With Adhesive Base.-#4065.
Device ID | K864188 |
510k Number | K864188 |
Device Name: | E-Z HOLD WITH ADHESIVE BASE.-#4065 |
Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
Applicant | JOHN F. GREER CO., INC. 530 E. 12TH ST. Oakland, CA 94606 |
Contact | Leland H Greer |
Correspondent | Leland H Greer JOHN F. GREER CO., INC. 530 E. 12TH ST. Oakland, CA 94606 |
Product Code | KNX |
CFR Regulation Number | 876.5250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-10-27 |
Decision Date | 1986-12-04 |