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510(k) K852620

SAFE.N.SURE by Ashai Co. , Ltd. — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1985
Date Received
June 20, 1985
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 Ashai Co. , Ltd.

  • K870428 — AEROSOL ONE, NEBULIZER PUMP (May 15, 1987)
  • K852622 — AEROSOL ONE (April 24, 1986)
  • K852627 — MAXI-NEB (September 26, 1985)
  • K852628 — NASAL ONE (September 18, 1985)
  • K852624 — OXY-TWO (September 18, 1985)
  • K852629 — AERO-MASK TWO (September 18, 1985)
  • K852626 — AERO-MASK ONE (September 18, 1985)
  • K852625 — OXY-TUBE (September 18, 1985)
  • K852623 — OXY-ONE (September 18, 1985)
  • K852618 — OXY-DIAL (September 18, 1985)

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