510(k) K780988
K780988 is an FDA 510(k) premarket notification submitted by Nestor Engineering Associates, Inc. for the device "DEVIN-NESTOR PNEUMATIC TOURNIQUET". The FDA issued a decision of Substantially Equivalent on Oct 3, 1978. The device falls under product code KCY (Tourniquet, Pneumatic), a Class I device regulated under 21 CFR 878.5910. Nestor Engineering Associates, Inc. has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 3, 1978
- Date Received
- Jun 14, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tourniquet, Pneumatic
- Device Class
- Class I
- Regulation Number
- 878.5910
- Review Panel
- SU
- Submission Type
- 510(k) Exempt