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FDA 510(k)

WIENER LAB. STANDATROL S-E 2 NIVELES, LOVELS 1&2: 3X5 ML VIALS CAT.NR.1937553

K-Number: K030482 · 2003-03-19

ApplicantWiener Laboratories
Decision Date2003-03-19
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

WIENER LAB. STANDATROL S-E 2 NIVELES, LOVELS 1&2: 3X5 ML VIALS CAT.NR.1937553 is the device name listed in this FDA 510(k) record. The listed applicant is Wiener Laboratories. It received FDA 510(k) clearance on 2003-03-19 under 510(k) number K030482. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WIENER LAB. STANDATROL S-E 2 NIVELES, LOVELS 1&2: 3X5 ML VIALS CAT.NR.1937553?

WIENER LAB. STANDATROL S-E 2 NIVELES, LOVELS 1&2: 3X5 ML VIALS CAT.NR.1937553 is a medical device that received FDA 510(k) clearance on 2003-03-19. The listed applicant is Wiener Laboratories. The 510(k) number is K030482.

When did WIENER LAB. STANDATROL S-E 2 NIVELES, LOVELS 1&2: 3X5 ML VIALS CAT.NR.1937553 receive FDA 510(k) clearance?

WIENER LAB. STANDATROL S-E 2 NIVELES, LOVELS 1&2: 3X5 ML VIALS CAT.NR.1937553 received FDA 510(k) clearance on 2003-03-19, under 510(k) number K030482.

Who is the listed applicant for WIENER LAB. STANDATROL S-E 2 NIVELES, LOVELS 1&2: 3X5 ML VIALS CAT.NR.1937553?

The FDA 510(k) record lists Wiener Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WIENER LAB. STANDATROL S-E 2 NIVELES, LOVELS 1&2: 3X5 ML VIALS CAT.NR.1937553?

The FDA product code for WIENER LAB. STANDATROL S-E 2 NIVELES, LOVELS 1&2: 3X5 ML VIALS CAT.NR.1937553 is JJY.

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Official Source

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