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510(k) K926498

ENDOGRIP by Biomedix, Inc. — Product Code BTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 1993
Date Received
December 29, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheal (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5730
Review Panel
AN
Submission Type

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  • K973857 — FLOSTAT VASCULAR REPORT GENERATOR (VRG) (December 29, 1997)
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  • K961928 — BIOMEDIX I.V. EXTENSION LINE W/ STOPCOCK MODEL B50-102/B51-102 (September 16, 1996)
  • K925645 — SELEC-3 (September 27, 1993)

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