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510(k) K863483

CASSETTE EMBOSSEER by Surgipath Medical Industries, Inc. — Product Code IDZ

K863483 is an FDA 510(k) premarket notification submitted by Surgipath Medical Industries, Inc. for the device "CASSETTE EMBOSSEER". The FDA issued a decision of Substantially Equivalent on September 16, 1986. The device falls under product code IDZ (Cassettes, Tissue), a Class I device regulated under 21 CFR 864.3010. Surgipath Medical Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1986
Date Received
September 9, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cassettes, Tissue
Device Class
Class I
Regulation Number
864.3010
Review Panel
PA
Submission Type

Other clearances by Surgipath Medical Industries, Inc.

  • K883217 — SCHIFF REAGENT (August 5, 1988)
  • K881921 — C-E BRUSH (July 19, 1988)
  • K881922 — CYTOJARS PREFILLED WITH CYTOLOGY PRESERVATIVE (May 25, 1988)
  • K881659 — TISSUE SECTION ADHESIVE (April 21, 1988)
  • K863549 — REUSABLE/DISPOSABLE AUTOPSY KNIFE SET (September 30, 1986)
  • K863616 — KNIFE MAKER (September 25, 1986)
  • K863548 — ROTARY MICROTOME (September 19, 1986)
  • K863145 — CERVICAL SCRAPERS (August 19, 1986)
  • K861270 — BLUE RIBBON PARAFFIN INFILTRATION/EMBEDDING MED. (April 11, 1986)
  • K861201 — FORMALDEHYDE SOLUTION, 37% (April 11, 1986)

Other clearances for product code IDZ

  • K862457 — LYNX EL MICROSCOPY TISSUE PROCESSOR (July 16, 1986)
  • K833857 — MACLEAN-FOGG, TISSUE CASSETTES (December 2, 1983)
  • K831334 — TISSUE CASSETTES FOR PROCESSING-EM BED (May 25, 1983)
  • K760623 — LANCER PARAPLAST HISTO PROCESS CASSETTE (September 27, 1976)

FDA data resources