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510(k) K910253

LEEP REDIKIT by CooperSurgical, Inc. — Product Code HEE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1991
Date Received
January 22, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Anesthesia, Paracervical
Device Class
Class II
Regulation Number
884.5100
Review Panel
OB
Submission Type

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Other clearances for product code HEE

  • K052365 — CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE (October 17, 2005)
  • K021224 — ENDOCERVICAL BLOCK NEEDLE (July 12, 2002)
  • K000117 — AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLE (April 13, 2000)
  • K983897 — CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MODEL #'S 720209 3 (February 1, 1999)
  • K980238 — GYNEX EXTENDED REACH NEEDLE (August 21, 1998)
  • K973671 — ENDOCERVICAL BLOCK NEEDLE (November 26, 1997)
  • K954718 — ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE (February 29, 1996)
  • K910252 — POTOCKY NEDDLE (TM) DISPOSABLE INJECTION NEEDLE (March 4, 1991)