HEMO-DE— 510(k) K822784

Substantially Equivalent

Pmp Industries

FDA 510(k) clearance K822784 for HEMO-DE, Substantially Equivalent on 1982-11-05. Applicant: Pmp Industries. Device class: 1.

Clearance details

Applicant: Pmp Industries
Product code: Code KEM
Device class: Class 1
Regulation: 21 CFR 864.4010
Advisory panel: Pathology
Date received: 1982-09-14
Decision date: 1982-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anaheim, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KEM

K881282 — XYLENE1988-04-05
K874461 — HEMO-SOL1987-12-04
K861490 — PERMACLEAR SOLUTION CAT. NO. 49501986-05-06
K855109 — CLEARENE, CLEARING AGENT1986-01-07
K853694 — XYLENE SUBSTITUTE1985-10-22

Data sourced from openFDA. This site is unofficial and independent of the FDA.