510(k) K883473

SURGICAL CONNECTING TUBES by Westmark, Sterile Packing Systems, Inc. (Sps) — Product Code GAZ

K883473 is an FDA 510(k) premarket notification submitted by Westmark, Sterile Packing Systems, Inc. (Sps) for the device "SURGICAL CONNECTING TUBES". The FDA issued a decision of Substantially Equivalent on August 25, 1988. The device falls under product code GAZ (Tubing, Noninvasive), a Class II device regulated under 21 CFR 880.6740. Westmark, Sterile Packing Systems, Inc. (Sps) has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1988
Date Received
August 16, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubing, Noninvasive
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type