510(k) K983882
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