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510(k) K934084

BIOENTERICS ENDOLUMINA ILLUMINATING BOUGIE by Bioenterics Corp. — Product Code HMJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 1993
Date Received
August 20, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screen, Tangent, Projection, Battery-Powered
Device Class
Class I
Regulation Number
886.1810
Review Panel
OP
Submission Type

Other clearances by Bioenterics Corp.

  • K002838 — GASTRIC SUCTION AND DRAINAGE CATHETER (July 9, 2001)
  • K964561 — ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, (February 11, 1997)
  • K924753 — BIOENTRICS ENDOLUMINA ILLUMINATED BOUGIE (December 15, 1992)

Other clearances for product code HMJ

  • K924753 — BIOENTRICS ENDOLUMINA ILLUMINATED BOUGIE (December 15, 1992)