510(k) K901442

BAXTER D & C TRAY by Baxter Healthcare Corp — Product Code HCY

K901442 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "BAXTER D & C TRAY". The FDA issued a decision of Substantially Equivalent on July 26, 1990. The device falls under product code HCY (Curette, Uterine), a Class I device regulated under 21 CFR 884.4530. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1990
Date Received
March 27, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Curette, Uterine
Device Class
Class I
Regulation Number
884.4530
Review Panel
OB
Submission Type