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510(k) K932720

HM-0970 by Hill-Med, Inc. — Product Code HRM

K932720 is an FDA 510(k) premarket notification submitted by Hill-Med, Inc. for the device "HM-0970". The FDA issued a decision of Substantially Equivalent on September 7, 1993. The device falls under product code HRM (Microscope, Operating & Accessories, Ac-Powered, Ophthalmic), a Class I device regulated under 21 CFR 878.4700. Hill-Med, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 1993
Date Received
June 4, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
Device Class
Class I
Regulation Number
878.4700
Review Panel
SU
Submission Type

Other clearances by Hill-Med, Inc.

  • K993991 — HM-930 ELECTROSURGICAL UNIT (May 30, 2000)
  • K981781 — ELECTROSURGICAL UNIT (December 4, 1998)
  • K961473 — HM-88011 SOLID STATE ELECTR SURGICAL UNIT (May 7, 1996)
  • K951718 — HM-SPIRO (December 20, 1995)
  • K940140 — HM-CRYO (June 27, 1994)
  • K932896 — HM-0690 COLPOSCOPE (March 23, 1994)
  • K932782 — HM-0660 (March 23, 1994)
  • K932817 — HM-880 I (March 9, 1994)
  • K932818 — HM-880 (February 25, 1994)

Other clearances for product code HRM

  • K930439 — MARCO SURGISCOPE OPERATION MICROSCOPES (July 22, 1993)
  • K920641 — ALCON OPERATING MICROSCOPES (October 9, 1992)
  • K914956 — KEELER KONAN SPECULAR MICROSCOPE SP5500 (February 3, 1992)
  • K891584 — S 22 INSTRUMENT STAND (June 8, 1989)
  • K891001 — MICROSCOPE KNOB COVER, STERILE, DISPOSABLE (April 11, 1989)
  • K854440 — MODIFIED CLINICAL WIDEFIELD SPECULAR MICROSCOPE 50 (December 16, 1985)
  • K853855 — XTAL X-150 OPERATING MICROSCOPE (October 15, 1985)
  • K852586 — CROMIC SURGICAL MICROSCOPE MODEL MC-1 (July 30, 1985)
  • K852150 — CLINICAL WIDEFIELD SPECULAR MICRISCOPE 500 (June 3, 1985)
  • K850270 — CORNEAL LIGHT SHIELD (May 31, 1985)

FDA data resources