510(k) K003695
K003695 is an FDA 510(k) premarket notification submitted by Micro-Medical Devices, Inc. for the device "MICROSCOPE-STAINLESS STEEL/FIBER OPTIC: .5-2.6MM MODEL MMD 4500 SERIES AND 2.7-5.0MM MODEL MMD-4700 SERIES". The FDA issued a decision of Substantially Equivalent on February 14, 2001. The device falls under product code HRX (Arthroscope), a Class II device regulated under 21 CFR 888.1100. Micro-Medical Devices, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 14, 2001
- Date Received
- November 30, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Arthroscope
- Device Class
- Class II
- Regulation Number
- 888.1100
- Review Panel
- OR
- Submission Type
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).