510(k) K771915
K771915 is an FDA 510(k) premarket notification submitted by American Sterilizer Co. for the device "MICRO OSCILLATING SAW". The FDA issued a decision of Substantially Equivalent on Oct 21, 1977. The device falls under product code HTZ (Instrument, Cutting, Orthopedic), a Class I device regulated under 21 CFR 878.4800. American Sterilizer Co. has 35 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 21, 1977
- Date Received
- Oct 12, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Instrument, Cutting, Orthopedic
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type
- 510(k) Exempt