510(k) K930615

AUTOVAC CLOSED WOUND SUCTION SYSTEM by Boehringer Laboratories — Product Code GCY

K930615 is an FDA 510(k) premarket notification submitted by Boehringer Laboratories for the device "AUTOVAC CLOSED WOUND SUCTION SYSTEM". The FDA issued a decision of Substantially Equivalent on February 22, 1994. The device falls under product code GCY (Apparatus, Suction, Single Patient Use, Portable, Nonpowered), a Class I device regulated under 21 CFR 878.4680. Boehringer Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 1994
Date Received
February 5, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Device Class
Class I
Regulation Number
878.4680
Review Panel
SU
Submission Type