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510(k) K941391

INFLATABLE RETENTION CUFF SPECULUM by Innovatec Medical Corp. — Product Code GBT

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 20, 1994
Date Received: March 22, 1994
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Catheter, Rectal
Device Class: Class II
Regulation Number: 876.5980
Review Panel: GU
Submission Type