510(k) K760793

ADAPTER FOR ELLIK EVACUATOR by V. Mueller O.V. Baxter Healthcare Corp. — Product Code FFD

K760793 is an FDA 510(k) premarket notification submitted by V. Mueller O.V. Baxter Healthcare Corp. for the device "ADAPTER FOR ELLIK EVACUATOR". The FDA issued a decision of Substantially Equivalent on October 15, 1976. The device falls under product code FFD (Evacuator, Bladder, Manually Operated), a Class I device regulated under 21 CFR 876.4370. 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
October 15, 1976
Date Received
October 7, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Evacuator, Bladder, Manually Operated
Device Class
Class I
Regulation Number
876.4370
Review Panel
GU
Submission Type