510(k) K870100
K870100 is an FDA 510(k) premarket notification submitted by Orthopedic Systems, Inc. for the device "PLASTER STAND". The FDA issued a decision of Substantially Equivalent on January 28, 1987. The device falls under product code LGG (Instrument, Cast Application/Removal, Manual), a Class I device regulated under 21 CFR 888.5980. Orthopedic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 28, 1987
- Date Received
- January 9, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Cast Application/Removal, Manual
- Device Class
- Class I
- Regulation Number
- 888.5980
- Review Panel
- OR
- Submission Type