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510(k) K781459

MONOJECT SCALE MAGNIFIER by Sherwood Medical Industries — Product Code HJY

K781459 is an FDA 510(k) premarket notification submitted by Sherwood Medical Industries for the device "MONOJECT SCALE MAGNIFIER". The FDA issued a decision of Substantially Equivalent on October 24, 1978. The device falls under product code HJY (Reader, Bar, Ophthalmic), a Class I device regulated under 21 CFR 886.5800. Sherwood Medical Industries has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1978
Date Received
August 23, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reader, Bar, Ophthalmic
Device Class
Class I
Regulation Number
886.5800
Review Panel
OP
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)
  • K792013 — LANCER L-INA HUMAN REFERENCE SERUM (November 13, 1979)
  • K792014 — LANCER L-INA BUFFER, POLYMER, WASH SOLU (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)
  • K781060 — MONOJECT ENDOSSEOUS DENTAL IMPLANT (August 14, 1978)
  • K772149 — LANCER BIOPSY HOLDER (November 22, 1977)

FDA data resources