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510(k) K812201

PHOTOGRAPHIC EQUIPMENT by Reznik Instruments — Product Code FEM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1981
Date Received
August 4, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Photographic, For Endoscope (Exclude Light Sources)
Device Class
Class I
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Reznik Instruments

  • K812205 — FORCEP (October 26, 1981)
  • K812204 — UTERINE MANIPULATORS (October 13, 1981)
  • K812199 — TROCAR & TROCAR SLEEVES (October 13, 1981)
  • K812203 — ELECTROSURGICAL UNIT (October 13, 1981)
  • K812206 — LAPAROSCOPE (October 13, 1981)
  • K812202 — FIBER OPTIC LIGHT SOURCE (September 29, 1981)
  • K812200 — INSUFFLATOR (September 29, 1981)
  • K812198 — ACCESSORIES(PROBES, SUCTION TUBES, ETC.) (September 11, 1981)

Other clearances for product code FEM

  • K940152 — CAMERA COVER WITH TEAR TIP (October 28, 1994)
  • K812542 — POLAROID INSTANT ENDOCAMERA (October 19, 1981)
  • K792512 — POLAROID LAND CAMERA FOR ENDOSCOPY (December 20, 1979)