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510(k) K810568

PARAFFIN EMBEDDING MEDIUM by Surgipath Medical Industries, Inc. — Product Code KEO

K810568 is an FDA 510(k) premarket notification submitted by Surgipath Medical Industries, Inc. for the device "PARAFFIN EMBEDDING MEDIUM". The FDA issued a decision of Substantially Equivalent on March 17, 1981. The device falls under product code KEO (Formulations, Paraffin, All), a Class I device regulated under 21 CFR 864.4010. Surgipath Medical Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1981
Date Received
March 3, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Formulations, Paraffin, All
Device Class
Class I
Regulation Number
864.4010
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)
  • K863483 — CASSETTE EMBOSSEER (September 16, 1986)
  • K863145 — CERVICAL SCRAPERS (August 19, 1986)
  • K861201 — FORMALDEHYDE SOLUTION, 37% (April 11, 1986)

Other clearances for product code KEO

  • K893772 — TISSUE EMBEDDING MEDIUM (June 22, 1989)
  • K862223 — MICRO THIN* PARAFFIN (June 17, 1986)
  • K862141 — HISTOLOGY PARAFFIN (June 13, 1986)
  • K861270 — BLUE RIBBON PARAFFIN INFILTRATION/EMBEDDING MED. (April 11, 1986)
  • K842053 — PARAPLAST EXTRA TISSUE EMBEDDING MED. (June 26, 1984)
  • K833071 — TECHNICON PARACUT (October 14, 1983)
  • K831580 — PARAFFIN INFILTRATION MEDIUM (June 17, 1983)
  • K812191 — VASPAR SEALENT (August 31, 1981)
  • K803241 — HISTOLOGICAL EMBEDDING MEDIA (January 28, 1981)
  • K760602 — SORVALL EMBEDDING MEDIUM (September 21, 1976)

FDA data resources