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510(k) K853295

EMODREN EXCHANGEABLE PLASTIC BELLOWS by Parexel Intl. Corp. — Product Code GCY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 1985
Date Received
August 6, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Device Class
Class I
Regulation Number
878.4680
Review Panel
SU
Submission Type

Other clearances by Parexel Intl. Corp.

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  • K904902 — SMA 26 TRANSDUCER (March 26, 1991)
  • K904901 — L11, L12 LINEAR AND C11, C12 CONVEX ARRAY TRANSDUC (March 26, 1991)
  • K884800 — ACTA GENOS ELECTROCARDIOGRAPH (June 22, 1989)
  • K862414 — FUJI CR IMAGING PLATE (February 26, 1987)
  • K864519 — PHILIPS COMPUTED RADIOGRAPHY SYSTEM (PCR) (February 13, 1987)
  • K862416 — FTI 100 MEDICAL THERMAL IMAGER (July 1, 1986)
  • K862415 — TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM (July 1, 1986)
  • K853296 — EMODREN GUIDE NEEDLE FOR DRAINAGE TUBE & EMODREN (August 15, 1985)
  • K851322 — PERSONAL C3 3-CHANNEL ELECTROCARDIOGRAPH (May 16, 1985)

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  • K963839 — CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500 (December 12, 1996)
  • K960099 — PENROSE DRAIN MODELS 6001 - 6007 (March 11, 1996)
  • K950754 — MACRO SUCTION TUBE MODEL NO 10061 (April 25, 1995)
  • K936223 — PRESSURE IRRIGATING SYSTEM (May 12, 1994)
  • K930615 — AUTOVAC CLOSED WOUND SUCTION SYSTEM (February 22, 1994)
  • K933319 — BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTE (October 27, 1993)
  • K933305 — IMC 5.0MM IRRIGATION/ASPIRATION PROBE (October 5, 1993)
  • K933306 — IMC 5.0MM IRRIGATION/ASPIRATION PROBE W/HOLES (October 5, 1993)