510(k) K801737
K801737 is an FDA 510(k) premarket notification submitted by Amsco Co. for the device "STERNUM SAW". The FDA issued a decision of Substantially Equivalent on August 20, 1980. The device falls under product code KFK (Saw, Pneumatically Powered), a Class I device regulated under 21 CFR 878.4820. Amsco Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 20, 1980
- Date Received
- July 25, 1980
- 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