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510(k) K853296

EMODREN GUIDE NEEDLE FOR DRAINAGE TUBE & EMODREN by Parexel Intl. Corp. — Product Code BYY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1985
Date Received
August 6, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Aspirating, Flexible, Connecting
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type

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Other clearances for product code BYY

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  • K960218 — CONNECTING TUBING (March 28, 1996)
  • K955149 — MAXI-FLOW SUCTION HANDLE/THE REEL THING TUBING REEL (January 24, 1996)
  • K955151 — MAXI-FLOW SUCTION TUBE/TOP GUN SUCTION IRRIGATOR (January 24, 1996)
  • K955150 — MAXI-FLOW (January 23, 1996)
  • K922989 — WILTEK IRRIGAITON/ASPIRATION TUBE SET (February 15, 1994)
  • K911586 — GENERAL HOSPITAL TUBING CLAMP (NON-ELECTRIC) (July 2, 1991)
  • K901761 — STERILE SUCTION TUBING SET (May 7, 1990)
  • K873463 — VAN DELLEN ASPIRATING TUBING (November 23, 1987)
  • K843470 — PHARMA-PLAST CONNECTING TUBE TYPE SUCT- (November 16, 1984)