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510(k) K871313

ULTRA-FRESH DEODORANT by Mentor Corp. — Product Code GDS

K871313 is an FDA 510(k) premarket notification submitted by Mentor Corp. for the device "ULTRA-FRESH DEODORANT". The FDA issued a decision of Substantially Equivalent on March 2, 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
March 2, 1988
Date Received
April 1, 1987
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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  • K042851 — MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT (November 9, 2004)
  • K040959 — MENTOR GENESIS PENILE PROSTHESIS (October 29, 2004)
  • K031767 — MENTOR OBTAPE TRANS-OBTURATOR TAPE (July 17, 2003)
  • 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

  • K883023 — MODIFIED ULTRA-FRESH ODOR REDUCING COMPOUND (September 29, 1988)

FDA data resources