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510(k) K920549

SHARPE ENDONEEDLE HOLDER by Paladin Medical, Inc. — Product Code HET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 1992
Date Received
February 6, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laparoscope, Gynecologic (And Accessories)
Device Class
Class II
Regulation Number
884.1720
Review Panel
OB
Submission Type

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  • K971290 — STRATASYS FDM MEDMODELER SYSTEM (June 20, 1997)
  • K964222 — ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING (December 20, 1996)
  • K950054 — ENDO-BEND(TM) SHAVER (June 29, 1995)
  • K935220 — CORE PREVENT MATTRESS MODIFICATION (November 29, 1993)
  • K921015 — SHARPE ENDOSPONGE ASPIIRATOR (May 21, 1993)
  • K915743 — SHARPE ENDOTENACULUM (May 20, 1993)
  • K921888 — SHARPE ENDODISSECTOR (October 20, 1992)
  • K915744 — SHARPE ENDOHEMOSTAT (October 20, 1992)

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