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510(k) K991118

O.B. APPLICATOR TAMPONS, O.B. TAMPONS by Personal Products Co. — Product Code HEB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 1999
Date Received
April 1, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tampon, Menstrual, Unscented
Device Class
Class II
Regulation Number
884.5470
Review Panel
OB
Submission Type

An unscented menstrual tampon is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual fluid or other vaginal discharge.

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  • K990536 — O.B. TAMPON (August 31, 1999)
  • K974629 — O.B. APPLICATOR AND NON-APPLICATOR TAMPONS (February 10, 1998)
  • K971589 — REACH ANTIBACTERIAL TOOTHBRUSH (July 24, 1997)
  • K970954 — O.B. APPLICATOR TAMPONS (June 10, 1997)
  • K961119 — CAREFREE PANTYLINERS (April 17, 1996)
  • K953638 — O.B. APPLICATOR TAMPONS (October 20, 1995)
  • K941863 — O.B. TAMPON (June 27, 1994)

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