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510(k) K885125

KRUPIN EYE VALVE W/SCLERAL BUCKLE by Hood Laboratories — Product Code KYF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1989
Date Received
December 12, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Eye Valve
Device Class
Class II
Regulation Number
886.3920
Review Panel
OP
Submission Type

Other clearances by Hood Laboratories

  • K921452 — ACOUSTIC RHINOMETER (July 8, 1993)
  • K920994 — HOOD NASAL SEPTAL BUTTON (May 15, 1992)
  • K905703 — KRUPIN EYE VALVE WITH DISK (March 15, 1991)
  • K904821 — ELIACHAR MODIFIED ESOPHAGEAL STENT (January 14, 1991)
  • K897049 — GIBSON ENDOLYMPHATIC SHUNT (March 16, 1990)
  • K897059 — HOOD SPEAKING VALVE (March 12, 1990)
  • K893866 — HOOD PEDIATRIC TRACHEOSTOMY TUBE (August 7, 1989)
  • K884810 — SILICONE LARYNGEAL STENT (May 10, 1989)
  • K890599 — HOOD NASAL SPLINT (March 17, 1989)
  • K882430 — HOOD TRACHEAL STOMA BUTTON (June 28, 1988)

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