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FDA 510(k)

PRO-MOLD, CUSTOM EAR

K-Number: K781491 · 1978-09-27

ApplicantMcghan Medical Corp.
Decision Date1978-09-27
Product CodeEWD
DecisionSubstantially Equivalent

Device Summary

PRO-MOLD, CUSTOM EAR is the device name listed in this FDA 510(k) record. The listed applicant is Mcghan Medical Corp.. It received FDA 510(k) clearance on 1978-09-27 under 510(k) number K781491. The device is classified under product code EWD. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRO-MOLD, CUSTOM EAR?

PRO-MOLD, CUSTOM EAR is a medical device that received FDA 510(k) clearance on 1978-09-27. The listed applicant is Mcghan Medical Corp.. The 510(k) number is K781491.

When did PRO-MOLD, CUSTOM EAR receive FDA 510(k) clearance?

PRO-MOLD, CUSTOM EAR received FDA 510(k) clearance on 1978-09-27, under 510(k) number K781491.

Who is the listed applicant for PRO-MOLD, CUSTOM EAR?

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

What is the FDA product code for PRO-MOLD, CUSTOM EAR?

The FDA product code for PRO-MOLD, CUSTOM EAR is EWD.

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Other records listing Mcghan Medical Corp. as applicant

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.

K873475MICRO-TORQUE HAND ENGINE & ACCESS. DERMABRA. BURSK873476MINI-MOTOR HAND ENGINE & ACCESS. DERMABRASION BURSK870754MCGHAN TISSUE EXPANDER FILL SYSTEMK864185MCGHAN LONGTERM MAMMARY EXPANDER, RTV DESIGNK864184MCGHAN LONGTERM MAMMARY EXPANDER/GEL-SALINE DESIGNK862203MCGHAN MAGNA-SITE(TM) TISSUE EXPANDER

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Related Devices (Code: EWD)

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.

K020296ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057Apothecary Products, Inc.K972923SUPER SILIPLUGS EAR PLUGSInterview Medical Technology Corp.K971517SILICONE PUTTY EAR PLUGSBentec Medical, Inc.K962292HEARSAVEREmtech LaboratoriesK960500THE VIRTUAL M-332Virtual Corp.K945376DOC'S PROPLUGS EAR PLUGSDoc'S Proplugs, Inc.

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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