510(k) K770873

CIRCUMCISION KIT by American Hospital Supply Corp. — Product Code FHG

K770873 is an FDA 510(k) premarket notification submitted by American Hospital Supply Corp. for the device "CIRCUMCISION KIT". The FDA issued a decision of Substantially Equivalent on July 11, 1977. The device falls under product code FHG (Bell, Circumcision), a Class II device regulated under 21 CFR 884.4530. American Hospital Supply Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 1977
Date Received
May 13, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bell, Circumcision
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type