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510(k) K924753

BIOENTRICS ENDOLUMINA ILLUMINATED BOUGIE by Bioenterics Corp. — Product Code HMJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 1992
Date Received
September 22, 1992
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)
  • K934084 — BIOENTERICS ENDOLUMINA ILLUMINATING BOUGIE (December 16, 1993)

Other clearances for product code HMJ

  • K934084 — BIOENTERICS ENDOLUMINA ILLUMINATING BOUGIE (December 16, 1993)