The following data is part of a premarket notification filed by Medical Technologies Of Georgia with the FDA for Readycath Catheter.
Device ID | K973120 |
510k Number | K973120 |
Device Name: | READYCATH CATHETER |
Classification | Catheter, Urethral |
Applicant | MEDICAL TECHNOLOGIES OF GEORGIA 5335-A DIVIDEND DR. Decatur, GA 30035 |
Contact | Richard Starke |
Correspondent | Richard Starke MEDICAL TECHNOLOGIES OF GEORGIA 5335-A DIVIDEND DR. Decatur, GA 30035 |
Product Code | GBM |
CFR Regulation Number | 876.5130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-08-20 |
Decision Date | 1998-02-25 |