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FDA 510(k)

CAPSULS, MODELS 2003-PUR8C, 2004-PVC8C

K-Number: K052798 · 2006-06-06

ApplicantIsovac Products, LLC
Decision Date2006-06-06
Product CodeLGN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CAPSULS, MODELS 2003-PUR8C, 2004-PVC8C is the device name listed in this FDA 510(k) record. The listed applicant is Isovac Products, LLC. It received FDA 510(k) clearance on 2006-06-06 under 510(k) number K052798. The device is classified under product code LGN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAPSULS, MODELS 2003-PUR8C, 2004-PVC8C?

CAPSULS, MODELS 2003-PUR8C, 2004-PVC8C is a medical device that received FDA 510(k) clearance on 2006-06-06. The listed applicant is Isovac Products, LLC. The 510(k) number is K052798.

When did CAPSULS, MODELS 2003-PUR8C, 2004-PVC8C receive FDA 510(k) clearance?

CAPSULS, MODELS 2003-PUR8C, 2004-PVC8C received FDA 510(k) clearance on 2006-06-06, under 510(k) number K052798.

Who is the listed applicant for CAPSULS, MODELS 2003-PUR8C, 2004-PVC8C?

The FDA 510(k) record lists Isovac Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAPSULS, MODELS 2003-PUR8C, 2004-PVC8C?

The FDA product code for CAPSULS, MODELS 2003-PUR8C, 2004-PVC8C is LGN.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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