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510(k) K831335

DISPOSABLE BASE MOLD by Surgipath Medical Industries, Inc. — Product Code KER

K831335 is an FDA 510(k) premarket notification submitted by Surgipath Medical Industries, Inc. for the device "DISPOSABLE BASE MOLD". The FDA issued a decision of Substantially Equivalent on May 16, 1983. The device falls under product code KER (Container, Embedding), 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
May 16, 1983
Date Received
April 25, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, Embedding
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)
  • K863483 — CASSETTE EMBOSSEER (September 16, 1986)
  • K863145 — CERVICAL SCRAPERS (August 19, 1986)
  • K861201 — FORMALDEHYDE SOLUTION, 37% (April 11, 1986)

Other clearances for product code KER

  • K831922 — EMBEDDING RING (July 29, 1983)
  • K831900 — MACLEAN-FOGG, DISP. BASE MOLD (July 28, 1983)
  • K831333 — EMBEDDING RINGS (May 25, 1983)
  • K772149 — LANCER BIOPSY HOLDER (November 22, 1977)

FDA data resources