510(k) K870084
K870084 is an FDA 510(k) premarket notification submitted by Terray Manufacturing, Inc. for the device "RD 140 SURGICAL BENDER". The FDA issued a decision of Substantially Equivalent on January 28, 1987. The device falls under product code HXW (Bender), a Class I device regulated under 21 CFR 888.4540. Terray Manufacturing, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 28, 1987
- Date Received
- January 8, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bender
- Device Class
- Class I
- Regulation Number
- 888.4540
- Review Panel
- OR
- Submission Type