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510(k) K872951

AMERICAN BRAIN RETRACTOR COVER by American Silk Sutures, Inc. — Product Code GET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1987
Date Received
July 28, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Motor, Surgical Instrument, Pneumatic Powered
Device Class
Class I
Regulation Number
878.4820
Review Panel
SU
Submission Type

Other clearances by American Silk Sutures, Inc.

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  • K872810 — STRUNG DENTAL ROLLS (December 4, 1987)
  • K872905 — AMERICAN NASAL SPONGE (September 4, 1987)
  • K872906 — SUCTION TUBE TIP FITS OVER BUSSIE FRAZIER TUBE (August 11, 1987)
  • K872807 — NON-WOVEN TRACHEOTOMY SPONGE (August 4, 1987)
  • K872809 — GAUZE CHERRY SPONGE (August 4, 1987)
  • K872806 — STICK SPONGE, STRUNG TONSIL SPONGE DOUBLE STRUNG (August 4, 1987)
  • K872808 — CHEVRON TAPE DISSECTOR, 9/16 X 1/4, 9/16 X 1/8 (August 4, 1987)

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