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510(k) K772149

LANCER BIOPSY HOLDER by Sherwood Medical Industries — Product Code KER

K772149 is an FDA 510(k) premarket notification submitted by Sherwood Medical Industries for the device "LANCER BIOPSY HOLDER". The FDA issued a decision of Substantially Equivalent on November 22, 1977. The device falls under product code KER (Container, Embedding), a Class I device regulated under 21 CFR 864.3010. Sherwood Medical Industries has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1977
Date Received
November 14, 1977
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 Sherwood Medical Industries

  • K801070 — SHERWOOD DISPOSABLE ENDOMETRIAL SAMPLES (July 21, 1980)
  • K801071 — LANCER GLUCOSE RATE REAGENT KIT (May 23, 1980)
  • K792014 — LANCER L-INA BUFFER, POLYMER, WASH SOLU (November 13, 1979)
  • K792013 — LANCER L-INA HUMAN REFERENCE SERUM (November 13, 1979)
  • K782077 — LANCER ICE CUBE (April 3, 1979)
  • K790523 — ARGYLE ESOPHAGEAL STETHOSCOPE (March 27, 1979)
  • K790196 — MONOJECT ARTERIAL BLOOD SAMPLING DEVICE (March 13, 1979)
  • K790197 — REAGENT KIT, LANCER GLUCOSE (March 12, 1979)
  • K781459 — MONOJECT SCALE MAGNIFIER (October 24, 1978)
  • K781060 — MONOJECT ENDOSSEOUS DENTAL IMPLANT (August 14, 1978)

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)
  • K831335 — DISPOSABLE BASE MOLD (May 16, 1983)

FDA data resources