510(k) K930775

DISPOSABLE FORCEPS, HEMOSTATS, NEEDLE GUIDES, ETC by Falcon Instruments, Inc. — Product Code MDM

K930775 is an FDA 510(k) premarket notification submitted by Falcon Instruments, Inc. for the device "DISPOSABLE FORCEPS, HEMOSTATS, NEEDLE GUIDES, ETC". The FDA issued a decision of Substantially Equivalent on April 23, 1993. The device falls under product code MDM (Instrument, Manual, Surgical, General Use), a Class I device regulated under 21 CFR 878.4800. Falcon Instruments, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1993
Date Received
February 16, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Manual, Surgical, General Use
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type