510(k) K983882

MICRO ENDOSCOPE-STAINLESS STEEL, MODEL MMD-1300, MICRO ENDOSCOPE-POLYIMIDE,MODEL MMD-1400 by Micro-Medical Devices, Inc. — Product Code HXR

K983882 is an FDA 510(k) premarket notification submitted by Micro-Medical Devices, Inc. for the device "MICRO ENDOSCOPE-STAINLESS STEEL, MODEL MMD-1300, MICRO ENDOSCOPE-POLYIMIDE,MODEL MMD-1400". The FDA issued a decision of Substantially Equivalent on March 15, 1999. The device falls under product code HXR (Spatula, Orthopedic), a Class I device regulated under 21 CFR 878.4800. Micro-Medical Devices, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1999
Date Received
November 2, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spatula, Orthopedic
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type