510(k) K874022

PHARMASEAL WOUND IRRIGATION DEVICE by American Pharmaseal Div. Ahsc — Product Code FQH

K874022 is an FDA 510(k) premarket notification submitted by American Pharmaseal Div. Ahsc for the device "PHARMASEAL WOUND IRRIGATION DEVICE". The FDA issued a decision of Substantially Equivalent on December 30, 1987. The device falls under product code FQH (Lavage, Jet), a Class II device regulated under 21 CFR 880.5475. American Pharmaseal Div. Ahsc has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1987
Date Received
October 2, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lavage, Jet
Device Class
Class II
Regulation Number
880.5475
Review Panel
HO
Submission Type