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510(k) K874436

FLUID SAMPLING PACK by U.S. Mfg. & Management, Inc. — Product Code KSS

K874436 is an FDA 510(k) premarket notification submitted by U.S. Mfg. & Management, Inc. for the device "FLUID SAMPLING PACK". The FDA issued a decision of Substantially Equivalent on January 5, 1988. The device falls under product code KSS (Supplies, Blood-Bank), a Class I device regulated under 21 CFR 864.9050. U.S. Mfg. & Management, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 1988
Date Received
October 28, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Supplies, Blood-Bank
Device Class
Class I
Regulation Number
864.9050
Review Panel
HE
Submission Type

Other clearances by U.S. Mfg. & Management, Inc.

  • K920860 — CONTROLLED PASSIVE MOTION MACHINE (April 2, 1992)
  • K862335 — MODIFIED I.V. START, RE-START, PEDI AND GERI-KIT (July 24, 1986)
  • K853242 — I.V. START KIT, I.V. RESTART KIT, PEDI-KIT,GERI-KI (August 30, 1985)
  • K842999 — VENI-SHIELD (September 24, 1984)

Other clearances for product code KSS

  • K812892 — S/P SERUM DROPPER PIPETS (October 27, 1981)
  • K801516 — PRE-DENT SYSTEM MODIFIED (July 14, 1980)
  • K801386 — PRE-DENT SYSTEM OR PRE-DENT II (July 14, 1980)
  • K800736 — PRE-DENT SYSTEM (April 24, 1980)
  • K761303 — IMMU-SAL IMMUNOHEMATOLOGICAL SALINE (December 30, 1976)

FDA data resources