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510(k) K891001

MICROSCOPE KNOB COVER, STERILE, DISPOSABLE by Prescott'S, Inc. — Product Code HRM

K891001 is an FDA 510(k) premarket notification submitted by Prescott'S, Inc. for the device "MICROSCOPE KNOB COVER, STERILE, DISPOSABLE". The FDA issued a decision of Substantially Equivalent on April 11, 1989. The device falls under product code HRM (Microscope, Operating & Accessories, Ac-Powered, Ophthalmic), a Class I device regulated under 21 CFR 878.4700. Prescott'S, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 1989
Date Received
February 27, 1989
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 Prescott'S, Inc.

  • K003842 — PRESCOTT'S SURGICAL SPEAR (April 13, 2001)

Other clearances for product code HRM

  • K932720 — HM-0970 (September 7, 1993)
  • 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)
  • 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