510(k) K864846
K864846 is an FDA 510(k) premarket notification submitted by American Sterilizer Co. for the device "RADIOGRAPHIC - LEG SECTION". The FDA issued a decision of Substantially Equivalent on December 24, 1986. The device falls under product code KQS (Table, Cystometric, Non-Electric And Accessories), a Class I device regulated under 21 CFR 876.4890. American Sterilizer Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 24, 1986
- Date Received
- December 10, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Table, Cystometric, Non-Electric And Accessories
- Device Class
- Class I
- Regulation Number
- 876.4890
- Review Panel
- GU
- Submission Type