510(k) K962329

GLOBAL LOSS OF RESISTANCE SYRINGE GLOR 10 by Global Medical Prods, Inc. — Product Code FMF

K962329 is an FDA 510(k) premarket notification submitted by Global Medical Prods, Inc. for the device "GLOBAL LOSS OF RESISTANCE SYRINGE GLOR 10". The FDA issued a decision of Substantially Equivalent on September 12, 1996. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Global Medical Prods, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1996
Date Received
June 17, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type