Home / 510(k) Clearances / K990925

510(k) K990925

MALE NATURAL RUBBER LATEX CONDOM (WITH LUBRICATION) by Hardcover Products, Inc. — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1999
Date Received
March 19, 1999
Clearance Type
Abbreviated
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 Hardcover Products, Inc.

  • K991047 — HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE) (June 18, 1999)

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