510(k) K870767
K870767 is an FDA 510(k) premarket notification submitted by Twin City Surgical, Inc. for the device "THE (CROM) TESTER". The FDA issued a decision of Substantially Equivalent on March 17, 1987. The device falls under product code KQW (Goniometer, Nonpowered), a Class I device regulated under 21 CFR 888.1520. Twin City Surgical, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 17, 1987
- Date Received
- February 26, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Goniometer, Nonpowered
- Device Class
- Class I
- Regulation Number
- 888.1520
- Review Panel
- NE
- Submission Type