510(k) K851474

VYGON SPINAL ANESTHESIA TRAY CODE NO. 190 by Vygon Corp. — Product Code LAZ

K851474 is an FDA 510(k) premarket notification submitted by Vygon Corp. for the device "VYGON SPINAL ANESTHESIA TRAY CODE NO. 190". The FDA issued a decision of Substantially Equivalent on May 7, 1985. The device falls under product code LAZ (N-Acetylprocainamide Control Materials), a Class I device regulated under 21 CFR 862.3280. Vygon Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 1985
Date Received
April 15, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
N-Acetylprocainamide Control Materials
Device Class
Class I
Regulation Number
862.3280
Review Panel
TX
Submission Type