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510(k) K820100

FROSTED GLASS SLIDES by Stan-Pak Ent. — Product Code KEW

K820100 is an FDA 510(k) premarket notification submitted by Stan-Pak Ent. for the device "FROSTED GLASS SLIDES". The FDA issued a decision of Substantially Equivalent on March 4, 1982. The device falls under product code KEW (Slides, Microscope), a Class I device regulated under 21 CFR 864.3010. Stan-Pak Ent. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1982
Date Received
January 13, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Slides, Microscope
Device Class
Class I
Regulation Number
864.3010
Review Panel
PA
Submission Type

Other clearances by Stan-Pak Ent.

  • K823058 — DOSOMETRIC RELEASE STERILIZATION (December 9, 1982)
  • K820099 — TRACH TAPE (February 23, 1982)
  • K820108 — TOPPER SPONGES (February 12, 1982)
  • K820106 — X-RAY GUAZE SPONGES (February 12, 1982)
  • K820155 — SPECIALIST CAST PADDING (February 12, 1982)
  • K820107 — GUAZE SPONGES, PLAIN (February 12, 1982)
  • K820140 — WEBRIL CAST PADDING (February 12, 1982)
  • K820105 — COMBINE PAD OR ABD (February 5, 1982)
  • K820056 — TELFA STRIPS (February 5, 1982)
  • K820139 — SOF-ROL CAST PADDING (February 5, 1982)

Other clearances for product code KEW

  • K891604 — THE CEN-SLIDE(TM) CENTRIFUGE TUBE (June 16, 1989)
  • K890042 — MICROSCOPE SLIDES PRECOATED (January 13, 1989)
  • K882357 — MICROSCOPE SLIDES PRECOATED W/HISTOGRIP & POLY-LY (June 16, 1988)
  • K831065 — SECTIONING AID KIT (June 8, 1983)
  • K813242 — QUANTIMETRIC 2 TEST KIT (December 2, 1981)
  • K800232 — ABCO ULTRA SLIDE MICROSCOPE SLIDE (February 21, 1980)
  • K760278 — SLIDE, LAB-TEK COVERED MICRO (August 30, 1976)

FDA data resources