510(k) K902676
K902676 is an FDA 510(k) premarket notification submitted by Micro-Aire Surgical Instruments, Inc. for the device "MICROGUARD, ORTHOPEDIC PIN PROTECTORS". The FDA issued a decision of Substantially Equivalent on September 14, 1990. The device falls under product code LYT (Fixation Accessory), a Class II device regulated under 21 CFR 888.3030. Micro-Aire Surgical Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 14, 1990
- Date Received
- June 19, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fixation Accessory
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type