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510(k) K973671

ENDOCERVICAL BLOCK NEEDLE by A & A Medical, Inc. — Product Code HEE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 1997
Date Received
September 26, 1997
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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  • K994256 — SUCTION IRRIGATION TRUMPET VALVE SET, MODEL Q65-823 (February 3, 2000)
  • K974038 — THE ASPIRATOR, 6FT SILICONE TUBING, METAL TUBING ADAPTER, GLASS RESERVOIR, NEOPR (May 11, 1998)

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)
  • 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)