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510(k) K862227

MODEL 8 & 20 ARGON LASER FOR PELVIC SURGERY IN GYN by Hgm, Inc. — Product Code HHR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1986
Date Received
June 11, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Surgical, Gynecologic
Device Class
Class II
Regulation Number
884.4550
Review Panel
OB
Submission Type

Other clearances by Hgm, Inc.

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  • K931784 — HGM ILLUMINATING IMAGING ENDOCULAR PROBE (March 1, 1994)
  • K933333 — HGM SCANMAN PLUS (September 23, 1993)
  • K931499 — Q-11 OPHTHALMIC LASER (August 19, 1993)
  • K925663 — HGM ASPIRATING ENDOOCULAR(TM) PROBE (August 17, 1993)
  • K930543 — E-25 KRYPTON ION LASER (SURGICA K5) (June 22, 1993)
  • K880908 — MODEL PC ARGON LASER (May 3, 1988)
  • K873773 — ENDOCOAGULATOR MODELS 8 AND 20 ARGON LASER (October 13, 1987)
  • K872630 — ENDOCOAGULATOR(TM) MODEL 20 ARGON LASER FOR UROLO. (August 25, 1987)

Other clearances for product code HHR

  • K881507 — ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES (April 27, 1989)
  • K871875 — MODEL 5050 SURGILASER FOR OB-GYN USE (August 22, 1988)
  • K875314 — GL-35 COLPOSCOPIC LASER SYSTEM (August 5, 1988)
  • K874615 — LASER CANNISTER FILTER (June 23, 1988)
  • K880591 — LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE (June 1, 1988)
  • K880930 — MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE (May 31, 1988)
  • K880991 — LASER OPTICAL CATHETER SYSTEM (May 25, 1988)
  • K880173 — MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION (March 24, 1988)
  • K874837 — KTP/532 LASER FOR OB-GYN USE (March 14, 1988)
  • K875078 — HERACURE LS 500 (February 22, 1988)