Home / 510(k) Clearances / K983320

510(k) K983320

ROYALE BRAND LATEX CONDOMS SILICONE LUBRICANT COLORED-OR ASSORTED COLORS by Suretex Prophylactics (India) , Ltd. — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1998
Date Received
September 21, 1998
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 Suretex Prophylactics (India) , Ltd.

  • K992081 — VARIOUS ANSELL TRADENAMES OR PRIVATE LABEL (August 19, 1999)
  • K981621 — ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS (June 19, 1998)

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