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510(k) K933604

QB II BLUNT DISSECTOR by Joyce M. Shotwell, M.D. — Product Code FGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1993
Date Received
July 27, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Carrier, Sponge, Endoscopic
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances for product code FGS

  • K931854 — ENDOSCOPIC BLUNT DISSECTING INSTRUMENT (August 10, 1993)
  • K923818 — O.R. CONCEPTS' IRRIGATING KITTNER (April 7, 1993)
  • K822194 — ENDOSCOPIC SPONGE CARRIER (August 27, 1982)