The following data is part of a premarket notification filed by Medical Technologies Of Georgia with the FDA for Mmg External Female Catheters.
Device ID | K854821 |
510k Number | K854821 |
Device Name: | MMG EXTERNAL FEMALE CATHETERS |
Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
Applicant | MEDICAL TECHNOLOGIES OF GEORGIA P.O. BOX 291 417 GLENDALE ROAD Wilbraham, MA 01095 -0291 |
Contact | Timothy D Golden |
Correspondent | Timothy D Golden MEDICAL TECHNOLOGIES OF GEORGIA P.O. BOX 291 417 GLENDALE ROAD Wilbraham, MA 01095 -0291 |
Product Code | KNX |
CFR Regulation Number | 876.5250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-12-03 |
Decision Date | 1986-04-24 |