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510(k) K800213

PHARMACY ADDITIVE SYRINGE SET by Cutter Laboratories, Inc. — Product Code KYW

K800213 is an FDA 510(k) premarket notification submitted by Cutter Laboratories, Inc. for the device "PHARMACY ADDITIVE SYRINGE SET". The FDA issued a decision of Substantially Equivalent on February 26, 1980. The device falls under product code KYW (Container, Liquid Medication, Graduated), a Class I device regulated under 21 CFR 880.6430. Cutter Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1980
Date Received
February 1, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, Liquid Medication, Graduated
Device Class
Class I
Regulation Number
880.6430
Review Panel
HO
Submission Type

Other clearances by Cutter Laboratories, Inc.

  • K861315 — HYPERBARIC PENETRATION EXTENSION SET (May 21, 1986)
  • K854106 — BAYSILEX (March 17, 1986)
  • K842324 — PERFOURM (November 9, 1984)
  • K834106 — INTRAVENOUS INFUSION CONTROLLER (May 30, 1984)
  • K832237 — ORTHOPEDIC CASTING TAPE MAXCAST (August 16, 1983)
  • K823214 — DOSIMETRIC RELEASE PROGRAM - ADMIN. SET (January 12, 1983)
  • K821326 — CUTTER BOND POLYCARBOXYLATE CEMENT (May 28, 1982)
  • K813532 — CUTTERBOND ZINC PHOSPHATE CEMENT (March 2, 1982)
  • K802104 — C-SPLINT (September 16, 1980)
  • K802105 — C-BLADE (September 16, 1980)

Other clearances for product code KYW

  • K791345 — MEDICINE CUP (August 3, 1979)

FDA data resources