510(k) K864555

3 RING ATTACHMENT by Professional Medical Services — Product Code FMF

K864555 is an FDA 510(k) premarket notification submitted by Professional Medical Services for the device "3 RING ATTACHMENT". The FDA issued a decision of Substantially Equivalent on December 1, 1986. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Professional Medical Services has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 1986
Date Received
November 19, 1986
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