510(k) K800861

SNYDER HEMOVAC CHEST DRAINAGE SOLUTION by Snyder Laboratories, Inc. — Product Code KDQ

K800861 is an FDA 510(k) premarket notification submitted by Snyder Laboratories, Inc. for the device "SNYDER HEMOVAC CHEST DRAINAGE SOLUTION". The FDA issued a decision of Substantially Equivalent on May 2, 1980. The device falls under product code KDQ (Bottle, Collection, Vacuum), a Class II device regulated under 21 CFR 880.6740. Snyder Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1980
Date Received
April 16, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bottle, Collection, Vacuum
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type