The following data is part of a premarket notification filed by Medical Marketing Group with the FDA for O'neil Urinary Catheter Introducer.
Device ID | K884819 |
510k Number | K884819 |
Device Name: | O'NEIL URINARY CATHETER INTRODUCER |
Classification | Accessories, Catheter, G-u |
Applicant | MEDICAL MARKETING GROUP 5335 DIVIDEND DR. Decatur, GA 30035 |
Contact | Timothy D Golden |
Correspondent | Timothy D Golden MEDICAL MARKETING GROUP 5335 DIVIDEND DR. Decatur, GA 30035 |
Product Code | KNY |
CFR Regulation Number | 876.5130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-11-17 |
Decision Date | 1989-02-17 |