510(k) K760172

OBTURATOR, VISUAL by V. Mueller O.V. Baxter Healthcare Corp. — Product Code FEC

K760172 is an FDA 510(k) premarket notification submitted by V. Mueller O.V. Baxter Healthcare Corp. for the device "OBTURATOR, VISUAL". The FDA issued a decision of Substantially Equivalent on December 2, 1976. The device falls under product code FEC (Obturator, For Endoscope), a Class II device regulated under 21 CFR 876.1500. V. Mueller O.V. Baxter Healthcare Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 1976
Date Received
July 6, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Obturator, For Endoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type