510(k) K922396

FUJINON FORCEPS -- MODIFICATION by Hobbs Medical, Inc. — Product Code FCL

K922396 is an FDA 510(k) premarket notification submitted by Hobbs Medical, Inc. for the device "FUJINON FORCEPS -- MODIFICATION". The FDA issued a decision of Substantially Equivalent on December 10, 1992. The device falls under product code FCL (Forceps, Biopsy, Non-Electric), a Class I device regulated under 21 CFR 876.1075. Hobbs Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1992
Date Received
May 19, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Biopsy, Non-Electric
Device Class
Class I
Regulation Number
876.1075
Review Panel
GU
Submission Type