510(k) K792369

HYPERALIMENTATION DRESSING TRAY by Pharmaseal Div., Baxter Healthcare Corp. — Product Code FRG

K792369 is an FDA 510(k) premarket notification submitted by Pharmaseal Div., Baxter Healthcare Corp. for the device "HYPERALIMENTATION DRESSING TRAY". The FDA issued a decision of Substantially Equivalent on December 10, 1979. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Pharmaseal Div., Baxter Healthcare Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1979
Date Received
September 24, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wrap, Sterilization
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type