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510(k) K792395

PHARMAFLEX CRYOGENIC BAG by Pharmachem Corp. — Product Code KSR

K792395 is an FDA 510(k) premarket notification submitted by Pharmachem Corp. for the device "PHARMAFLEX CRYOGENIC BAG". The FDA issued a decision of Substantially Equivalent on February 26, 1980. The device falls under product code KSR (Container, Empty, For Collection & Processing Of Blood & Blood Components), a Class II device regulated under 21 CFR 864.9100.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1980
Date Received
November 26, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, Empty, For Collection & Processing Of Blood & Blood Components
Device Class
Class II
Regulation Number
864.9100
Review Panel
HE
Submission Type

Other clearances for product code KSR

  • K032827 — KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501 (December 8, 2003)
  • K020753 — DEROYAL SURGICAL, UMBILICUP (June 13, 2002)
  • K810500 — BLOOD FREEZING BAG (September 23, 1981)
  • K810897 — ALPHA PLASTIC PLASMA BOTTLE (September 23, 1981)
  • K811523 — PLASMA FLEX (September 9, 1981)
  • K811449 — HAEMONETICS 1000ML COMPONENT BAG (July 1, 1981)
  • K810711 — HAEMONETICS 600 ML. COMPONENT BAG (May 8, 1981)
  • K810313 — HAEMONETICS 1400 ML THERAPEUTIC BAG (March 31, 1981)
  • K801082 — GAMBRO HEMOFREEZE-BAG (October 31, 1980)
  • K801219 — PLASMAPOOLER (October 31, 1980)

FDA data resources