510(k) K882640
K882640 is an FDA 510(k) premarket notification submitted by Tecnol New Jersey Wound Care, Inc. for the device "TECNOL SECURE-ALL PELVIC TRACTION BELT". The FDA issued a decision of Substantially Equivalent on July 27, 1988. The device falls under product code KQZ (Component, Traction, Non-Invasive), a Class I device regulated under 21 CFR 888.5890. Tecnol New Jersey Wound Care, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 27, 1988
- Date Received
- June 27, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Component, Traction, Non-Invasive
- Device Class
- Class I
- Regulation Number
- 888.5890
- Review Panel
- OR
- Submission Type