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510(k) K801260

DISPOSABLE PRESSURE LINE ADAPTOR by Intec Medical, Inc. — Product Code BYX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 1980
Date Received
May 28, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubing, Pressure And Accessories
Device Class
Class I
Regulation Number
868.5860
Review Panel
AN
Submission Type

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  • K903840 — GIANT LUMEN SAFETIP SERIES: ENDOMYOCARDIAL BIOPSY (October 16, 1990)
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  • K894925 — AMCATH URETERAL DILATORS MODELS 7100,7110,7120 (December 13, 1989)
  • K860941 — DISPOSABLE HEATED WIRE LOOPS 48 AND 72 (April 2, 1986)

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  • K931033 — MF CHEMETRON STYLE MEDICAL GAS WALL OUTLETS (June 1, 1993)
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  • K914980 — HEX, QUAD, OR RAIL BLOCK MANIFOLD ACCESSORIES (January 21, 1992)
  • K912763 — OHMEDA STYLE CHECK UNITS (FEMALE COUPLERS) (October 15, 1991)
  • K905091 — VARIOUS MALE QUICK CONNECTS. (March 4, 1991)