510(k) K771097

FORCEP, DISP., A CLAMP by Dravon Medical, Inc. — Product Code HTD

K771097 is an FDA 510(k) premarket notification submitted by Dravon Medical, Inc. for the device "FORCEP, DISP., A CLAMP". The FDA issued a decision of Substantially Equivalent on July 14, 1977. The device falls under product code HTD (Forceps), a Class I device regulated under 21 CFR 878.4800. Dravon Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1977
Date Received
June 20, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type