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FDA 510(k)

MEDCO CUSTOM EAR PROTECTOR MOLD KIT

K-Number: K821187 · 1982-05-27

ApplicantSanta Barbara Medco, Inc.
Decision Date1982-05-27
Product CodeEWD
DecisionSubstantially Equivalent

Device Summary

MEDCO CUSTOM EAR PROTECTOR MOLD KIT is the device name listed in this FDA 510(k) record. The listed applicant is Santa Barbara Medco, Inc.. It received FDA 510(k) clearance on 1982-05-27 under 510(k) number K821187. The device is classified under product code EWD. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDCO CUSTOM EAR PROTECTOR MOLD KIT?

MEDCO CUSTOM EAR PROTECTOR MOLD KIT is a medical device that received FDA 510(k) clearance on 1982-05-27. The listed applicant is Santa Barbara Medco, Inc.. The 510(k) number is K821187.

When did MEDCO CUSTOM EAR PROTECTOR MOLD KIT receive FDA 510(k) clearance?

MEDCO CUSTOM EAR PROTECTOR MOLD KIT received FDA 510(k) clearance on 1982-05-27, under 510(k) number K821187.

Who is the listed applicant for MEDCO CUSTOM EAR PROTECTOR MOLD KIT?

The FDA 510(k) record lists Santa Barbara Medco, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDCO CUSTOM EAR PROTECTOR MOLD KIT?

The FDA product code for MEDCO CUSTOM EAR PROTECTOR MOLD KIT is EWD.

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Other records listing Santa Barbara Medco, Inc. 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.

K850492NASAL SEPTAL BUTTONK842483SANTA BARBARA MEDCO-LANTOPHORETIC APPLICK823921PHYSICIANS CHOICE SILICONE EAR PUTTYK812069BORES* DEPTH GAUGEK812071RK IV SURGICAL BLADESK812070BORES* ADJUSTABLE BLADE HOLDER

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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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