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510(k) K822784

HEMO-DE by Pmp Industries — Product Code KEM

K822784 is an FDA 510(k) premarket notification submitted by Pmp Industries for the device "HEMO-DE". The FDA issued a decision of Substantially Equivalent on November 5, 1982. The device falls under product code KEM (Agent, Clearing), a Class I device regulated under 21 CFR 864.4010.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1982
Date Received
September 14, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agent, Clearing
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
Submission Type

Other clearances for product code KEM

  • K881282 — XYLENE (April 5, 1988)
  • K874461 — HEMO-SOL (December 4, 1987)
  • K861490 — PERMACLEAR SOLUTION CAT. NO. 4950 (May 6, 1986)
  • K855109 — CLEARENE, CLEARING AGENT (January 7, 1986)
  • K853694 — XYLENE SUBSTITUTE (October 22, 1985)
  • K854083 — XYLENE SUBSTITUTE MONTANT (October 22, 1985)
  • K842861 — PRO-PAR CLEARANT (August 21, 1984)
  • K842721 — LIMONENE (August 3, 1984)
  • K832011 — AMERI CLEAR (August 12, 1983)
  • K832451 — CLEAR-RITE 3 (August 12, 1983)

FDA data resources