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510(k) K052365

CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE by Rocket Medical Plc — Product Code HEE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2005
Date Received
August 29, 2005
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

  • K021224 — ENDOCERVICAL BLOCK NEEDLE (July 12, 2002)
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  • 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)
  • K910253 — LEEP REDIKIT (April 18, 1991)
  • K910252 — POTOCKY NEDDLE (TM) DISPOSABLE INJECTION NEEDLE (March 4, 1991)