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FDA 510(k)

DR. GOULD HAND PACK SUSTOM STERIL

K-Number: K842405 · 1984-08-15

ApplicantPro-Lab, Inc.
Decision Date1984-08-15
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DR. GOULD HAND PACK SUSTOM STERIL is the device name listed in this FDA 510(k) record. The listed applicant is Pro-Lab, Inc.. It received FDA 510(k) clearance on 1984-08-15 under 510(k) number K842405. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DR. GOULD HAND PACK SUSTOM STERIL?

DR. GOULD HAND PACK SUSTOM STERIL is a medical device that received FDA 510(k) clearance on 1984-08-15. The listed applicant is Pro-Lab, Inc.. The 510(k) number is K842405.

When did DR. GOULD HAND PACK SUSTOM STERIL receive FDA 510(k) clearance?

DR. GOULD HAND PACK SUSTOM STERIL received FDA 510(k) clearance on 1984-08-15, under 510(k) number K842405.

Who is the listed applicant for DR. GOULD HAND PACK SUSTOM STERIL?

The FDA 510(k) record lists Pro-Lab, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DR. GOULD HAND PACK SUSTOM STERIL?

The FDA product code for DR. GOULD HAND PACK SUSTOM STERIL is FRG.

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Related Devices (Code: FRG)

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Official Source

View on FDA Database →

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

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