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510(k) K883023

MODIFIED ULTRA-FRESH ODOR REDUCING COMPOUND by Mentor Corp. — Product Code GDS

K883023 is an FDA 510(k) premarket notification submitted by Mentor Corp. for the device "MODIFIED ULTRA-FRESH ODOR REDUCING COMPOUND". The FDA issued a decision of Substantially Equivalent on September 29, 1988. The device falls under product code GDS (Bag, Stomal), a Class I device regulated under 21 CFR 876.5900. Mentor Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1988
Date Received
July 19, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bag, Stomal
Device Class
Class I
Regulation Number
876.5900
Review Panel
GU
Submission Type

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  • K011493 — MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRA (October 1, 2002)
  • K011500 — MENTOR CONTOUR PROFILE TISSUE EXPANDER (December 3, 2001)
  • K004005 — MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENES (October 12, 2001)
  • K010709 — MENTOR STERILE SALINE MAMMARY VOLUME SIZERS (April 23, 2001)

Other clearances for product code GDS

  • K871313 — ULTRA-FRESH DEODORANT (March 2, 1988)

FDA data resources