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510(k) K932396

PERI-COMFORT(TM) SEATING CUSHION by Chi'Am Intl. — Product Code LRL

K932396 is an FDA 510(k) premarket notification submitted by Chi'Am Intl. for the device "PERI-COMFORT(TM) SEATING CUSHION". The FDA issued a decision of Substantially Equivalent on September 30, 1993. The device falls under product code LRL (Cushion, Hemorrhoid), a Class U device.

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 30, 1993
Date Received: May 18, 1993
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Cushion, Hemorrhoid
Device Class: Class U
Regulation Number
Review Panel: GU
Submission Type