The following data is part of a premarket notification filed by Global Medical Prods, Inc. with the FDA for Global Loss Of Resistance Syringe Glor 10.
Device ID | K962329 |
510k Number | K962329 |
Device Name: | GLOBAL LOSS OF RESISTANCE SYRINGE GLOR 10 |
Classification | Syringe, Piston |
Applicant | GLOBAL MEDICAL PRODS, INC. 244 MAIN ST. SOUTH P.O. 505 Woodbury, CT 06798 -0505 |
Contact | Peter Clark |
Correspondent | Peter Clark GLOBAL MEDICAL PRODS, INC. 244 MAIN ST. SOUTH P.O. 505 Woodbury, CT 06798 -0505 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-06-17 |
Decision Date | 1996-09-12 |