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510(k) K771359

ALLERGIST PACK SYRINGES by Pharmaseal Div., Baxter Healthcare Corp. — Product Code FMF

K771359 is an FDA 510(k) premarket notification submitted by Pharmaseal Div., Baxter Healthcare Corp. for the device "ALLERGIST PACK SYRINGES". The FDA issued a decision of Substantially Equivalent on August 22, 1977. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Pharmaseal Div., Baxter Healthcare Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 1977
Date Received
July 25, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

Other clearances by Pharmaseal Div., Baxter Healthcare Corp.

  • K792369 — HYPERALIMENTATION DRESSING TRAY (December 10, 1979)
  • K792141 — CONTINUOUS FLUSH DEVICE (December 5, 1979)
  • K792019 — PHADECODE XA INHIBITOR ASSAY (November 5, 1979)
  • K791773 — VENTILATOR TUBE WITH FILTER (October 22, 1979)
  • K791156 — AMIPAQUE MYELOGRAM TRAY (July 30, 1979)
  • K790896 — TWO-WAY ANESTHESIA FILTER (June 5, 1979)
  • K790409 — LOW DEAD SPACE INSULIN SYRINGE (April 24, 1979)
  • K782069 — TRAY, AUXILLARY BLOCK (January 4, 1979)
  • K781797 — PREP TRAY, PREOPERATIVE SKIN (November 8, 1978)
  • K781680 — MONITORING, PRESSURE KIT (October 6, 1978)

Other clearances for product code FMF

  • K262581 — GraftGun Universal Graft Delivery System (GDS®) (August 26, 2026)
  • K252184 — SOL-M Luer Lock Syringe with Exchangeable Needle Tray (August 25, 2026)
  • K253747 — Disposable Pen Injector (KXYC-03C02, KXYC-03A03) (August 14, 2026)
  • K260208 — Ultra-Fine™ SAFETY Insulin Syringe (July 13, 2026)
  • K253110 — Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe (June 18, 2026)
  • K260514 — Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low (June 12, 2026)
  • K253112 — Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); (May 21, 2026)
  • K252279 — Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) (April 17, 2026)
  • K253068 — Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe (February 23, 2026)
  • K253769 — Instylla Delivery Kit (December 22, 2025)

FDA data resources