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510(k) K891352

MARLOW ANAL SPECULUM by Simpson/Basye, Inc. — Product Code KOA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1989
Date Received
March 10, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Surgical Instruments, G-U, Manual (And Accessories)
Device Class
Class I
Regulation Number
876.4730
Review Panel
GU
Submission Type

Other clearances by Simpson/Basye, Inc.

  • K926179 — SEDLACEK HANDLE (March 25, 1994)
  • K891351 — NEWPORT LATERAL VAGINAL RETRACTOR (May 11, 1989)
  • K891349 — CAMPION CERVICAL HOOK (March 29, 1989)
  • K891350 — NEWPORT CERVICAL MANIPULATOR (March 29, 1989)
  • K891347 — REID ENDOCERVICAL SPREADER (March 29, 1989)
  • K891348 — CAMPION LASER FORCEPS (March 22, 1989)
  • K870276 — HEATED INSTRUMENT BATH (May 7, 1987)
  • K862717 — HAND MIRROR (ENDOSCOPE) (July 30, 1986)
  • K862629 — SURGICAL LASER ACCESSORIES (SLA) CASE (July 17, 1986)
  • K790923 — MI-MARK ENDOCERVICAL SAMPLING SET (June 22, 1979)

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  • K921546 — VASOVASOSTOMY SET (July 2, 1993)
  • K931181 — VESITEC SUTURE PASSER (May 12, 1993)
  • K921304 — DDV LIGATOR (October 5, 1992)
  • K922971 — NO-SCALPEL VASCETOMY INSTRUMENTS (September 23, 1992)
  • K921228 — BENDEREV PROTECT-A-PASS NEEDLE (September 14, 1992)
  • K922192 — VAS DILATOR (August 7, 1992)
  • K896058 — GRASPING FORCEPS (December 28, 1989)