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FDA 510(k)

DELIKIT PUTTY, DELIKIT HEAVY BODY, DELIKIT LIGHT BODY

K-Number: K103346 · 2011-02-11

ApplicantSherpa Korea
Decision Date2011-02-11
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DELIKIT PUTTY, DELIKIT HEAVY BODY, DELIKIT LIGHT BODY is the device name listed in this FDA 510(k) record. The listed applicant is Sherpa Korea. It received FDA 510(k) clearance on 2011-02-11 under 510(k) number K103346. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DELIKIT PUTTY, DELIKIT HEAVY BODY, DELIKIT LIGHT BODY?

DELIKIT PUTTY, DELIKIT HEAVY BODY, DELIKIT LIGHT BODY is a medical device that received FDA 510(k) clearance on 2011-02-11. The listed applicant is Sherpa Korea. The 510(k) number is K103346.

When did DELIKIT PUTTY, DELIKIT HEAVY BODY, DELIKIT LIGHT BODY receive FDA 510(k) clearance?

DELIKIT PUTTY, DELIKIT HEAVY BODY, DELIKIT LIGHT BODY received FDA 510(k) clearance on 2011-02-11, under 510(k) number K103346.

Who is the listed applicant for DELIKIT PUTTY, DELIKIT HEAVY BODY, DELIKIT LIGHT BODY?

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

What is the FDA product code for DELIKIT PUTTY, DELIKIT HEAVY BODY, DELIKIT LIGHT BODY?

The FDA product code for DELIKIT PUTTY, DELIKIT HEAVY BODY, DELIKIT LIGHT BODY is ELW.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: ELW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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