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510(k) K812202

FIBER OPTIC LIGHT SOURCE by Reznik Instruments — Product Code HIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1981
Date Received
August 4, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hysteroscope (And Accessories)
Device Class
Class II
Regulation Number
884.1690
Review Panel
OB
Submission Type

Other clearances by Reznik Instruments

  • K812205 — FORCEP (October 26, 1981)
  • K812201 — PHOTOGRAPHIC EQUIPMENT (October 19, 1981)
  • K812203 — ELECTROSURGICAL UNIT (October 13, 1981)
  • K812204 — UTERINE MANIPULATORS (October 13, 1981)
  • K812199 — TROCAR & TROCAR SLEEVES (October 13, 1981)
  • K812206 — LAPAROSCOPE (October 13, 1981)
  • K812200 — INSUFFLATOR (September 29, 1981)
  • K812198 — ACCESSORIES(PROBES, SUCTION TUBES, ETC.) (September 11, 1981)

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