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510(k) K781907

EAR STOPPLES FOR NOISE ATTENTION by Crown Delta Corp. — Product Code EWD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1978
Date Received
November 14, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Protector, Hearing (Insert)
Device Class
Class U
Regulation Number
Review Panel
EN
Submission Type

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  • K940132 — PODIATRIC MATERIAL (September 29, 1994)
  • K930248 — VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEM (January 7, 1994)
  • K926150 — VINYL ADDITION SILICONE SYSTEM (July 14, 1993)
  • K901991 — SILICONE ELASTOMER PUTTY (September 14, 1990)
  • K901990 — VINYL SILICONE ELASTOMER MATERIAL (September 14, 1990)
  • K872745 — VINYL POLYSILOXANE IMPRESSION SYSTEM (July 21, 1987)
  • K871409 — VINYL POLYSILOXANE IMPRESSION SYSTEM (June 11, 1987)

Other clearances for product code EWD

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  • K972923 — SUPER SILIPLUGS EAR PLUGS (October 27, 1997)
  • K971517 — SILICONE PUTTY EAR PLUGS (June 2, 1997)
  • K962292 — HEARSAVER (October 29, 1996)
  • K960500 — THE VIRTUAL M-332 (April 3, 1996)
  • K945376 — DOC'S PROPLUGS EAR PLUGS (November 14, 1995)
  • K930203 — MODEL 322 CLINICAL AUDIOMETER (July 8, 1993)
  • K915739 — #903 SILAFLEX II (June 30, 1992)
  • K910177 — SEAL-RITE SILICONE EAR PLUG (June 24, 1991)
  • K862045 — DOC'S PROPLUGS EAR PLUGS (April 10, 1987)