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510(k) K933310

MICRINS CONTRAST BACKGROUND MATERIAL by Micrins Surgical, Inc. — Product Code EPT

K933310 is an FDA 510(k) premarket notification submitted by Micrins Surgical, Inc. for the device "MICRINS CONTRAST BACKGROUND MATERIAL". The FDA issued a decision of Substantially Equivalent on August 19, 1993. The device falls under product code EPT (Microscope, Surgical), a Class I device regulated under 21 CFR 878.4700. Micrins Surgical, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1993
Date Received
July 7, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microscope, Surgical
Device Class
Class I
Regulation Number
878.4700
Review Panel
SU
Submission Type

Other clearances by Micrins Surgical, Inc.

  • K993970 — MICRINS MICROSURGICAL SUTURE (March 30, 2000)
  • K982278 — MICRINS MICRO ANASTOMOSIS CLAMP (March 26, 1999)
  • K872989 — MICRINS NEEDLE HOLDER (August 21, 1987)
  • K872990 — MICRINS SURGICAL SCISSOR (August 17, 1987)
  • K872991 — MICRINS FORCEPS 2010 (August 17, 1987)

Other clearances for product code EPT

  • K942233 — MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM (July 1, 1994)
  • K931284 — MICRODYNE OFFICE SURGICAL MICROSCOPE (November 18, 1993)
  • K903412 — STORZ MODEL M705 AND/OR M706 CEILING MOUNTED MICR. (September 20, 1990)
  • K883581 — OPMI CS (September 13, 1988)
  • K882269 — STORZ DIAGNOSTIC MICROSCOPE SYSTEM (June 23, 1988)
  • K860811 — ZEISS VOICE CONTROL SYSTEM FOR OPMI'S (April 30, 1986)
  • K844858 — STORZ/URBAN SURGICAL MICROSCOPE SYSTEM (March 25, 1985)
  • K832887 — ELECTRONIC UNIT (October 4, 1983)
  • K823011 — VC III (November 8, 1982)
  • K822561 — MICROSCOPE (September 14, 1982)

FDA data resources