510(k) K894301
K894301 is an FDA 510(k) premarket notification submitted by Micro Surgical Instruments Corp. for the device "MICRO-AIRE STERNUM SAW 4800". The FDA issued a decision of Substantially Equivalent on August 3, 1989. The device falls under product code KFK (Saw, Pneumatically Powered), a Class I device regulated under 21 CFR 878.4820. Micro Surgical Instruments Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 3, 1989
- Date Received
- June 23, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Saw, Pneumatically Powered
- Device Class
- Class I
- Regulation Number
- 878.4820
- Review Panel
- SU
- Submission Type