PEM-C— 510(k) K830397

Substantially Equivalent

Health Development Corp.

FDA 510(k) clearance K830397 for PEM-C, Substantially Equivalent on 1983-04-12. Applicant: Health Development Corp.. Device class: 1.

Clearance details

Applicant: Health Development Corp.
Product code: Code JSF
Device class: Class 1
Regulation: 21 CFR 866.2320
Advisory panel: Microbiology
Date received: 1983-02-07
Decision date: 1983-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JSF

K880946 — NUTRIENT GELATIN - PRODUCT NUMBER T28601988-04-01
K880119 — MOELLERS DECARBOXYLASE, ONITHINE1988-03-31
K880120 — MOELLERS DECARBOXYLASE, LYSINE1988-03-31
K880126 — LAURYL TRYPTOSE BROTH1988-03-31
K880106 — ACETAMIDE AGAR SLANT1988-03-30

More clearances from Health Development Corp.

K823937 — SEMINAL COLLECTION DEVICE1983-02-24
K810499 — PERCUTANEOUS GASTROINTESTINAL TUBE1981-03-04
K802482 — KEOFEED (R) EASY-FILL ENTERIC FEED BAG1980-10-31
K791714 — SURGIFEED1980-01-16

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