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510(k) K963321

OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODITE,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN by Custom Services Intl., Inc. — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1997
Date Received
August 12, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Condom
Device Class
Class II
Regulation Number
884.5300
Review Panel
OB
Submission Type

Other clearances by Custom Services Intl., Inc.

  • K972429 — INNERWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9 (September 10, 1997)
  • K972430 — EXTRAWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9 (September 10, 1997)
  • K972428 — EXTRAWEAR, GENTLEMEN'S CHOICE (August 25, 1997)
  • K972427 — INNERWEAR, JIMMY-O RAINCOAT, RAINCOAT, JASMINE, DRINK (August 20, 1997)
  • K970791 — INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE/JASMINE/DRINK/NAUGH (June 3, 1997)
  • K970767 — CONDOM (RUBBER), LUBRICATED, EXTRA STRENGTH (June 2, 1997)
  • K963322 — OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODITE,ZEUS,APOLLO,SELFCARE,CAREP (January 22, 1997)
  • K963319 — OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODIT,ZEUS,APOLLO,SELFCARE,CAREPL (January 22, 1997)

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