510(k) K921461

TURKEL THORACENTESIS NEEDLE by Symbiosis Corp. — Product Code GSS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1992
Date Received
March 27, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Fluorescent, Pseudomonas Aeruginosa
Device Class
Class II
Regulation Number
866.3415
Review Panel
MI
Submission Type