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510(k) K761338

LEFF STETHOSCOPE FOR FETAL HEART by J. Sklar Mfg. Co., Inc. — Product Code HGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1977
Date Received
December 27, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stethoscope, Fetal
Device Class
Class I
Regulation Number
884.2900
Review Panel
OB
Submission Type

Other clearances by J. Sklar Mfg. Co., Inc.

  • K843693 — JACOBS HIGH VACUUM SUCTION UNIT 05-2570 (October 31, 1984)
  • K842112 — TISCHLER CERVICAL BIOPSY PUNCH FORCEPS (July 3, 1984)
  • K842111 — KOGAN ENDOSPECULUM 9-1/2 (June 19, 1984)
  • K822448 — SCISSORS, VARIOUS (September 14, 1982)
  • K802457 — KEVORKIAN-YOUNGE BIOPSY PUNCH, #90-6610 (January 12, 1981)
  • K802458 — KEVORKIAN-YOUNGE BIOPSY CURETTE #90-6611 (January 12, 1981)
  • K801273 — MAGILL CATHETER INTRO. FORCEPS (July 28, 1980)
  • K800441 — RUDD-CLINIC HEMORRHOIDAL FORCEPS (April 8, 1980)
  • K790577 — HEMORRHOIDAL LIGATOR (April 23, 1979)
  • K772229 — MINICLAMPS, STABILIZ., FALLOPIAN TUBE (January 3, 1978)

Other clearances for product code HGN

  • K813298 — CONPHAR DELEE HILLIS STETHOSCOPE (December 8, 1981)