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FDA 510(k)

PHYSICIANS CHOICE SILICONE EAR PUTTY

K-Number: K823921 · 1983-03-28

ApplicantSanta Barbara Medco, Inc.
Decision Date1983-03-28
Product CodeLDG
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PHYSICIANS CHOICE SILICONE EAR PUTTY 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 1983-03-28 under 510(k) number K823921. The device is classified under product code LDG. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHYSICIANS CHOICE SILICONE EAR PUTTY?

PHYSICIANS CHOICE SILICONE EAR PUTTY is a medical device that received FDA 510(k) clearance on 1983-03-28. The listed applicant is Santa Barbara Medco, Inc.. The 510(k) number is K823921.

When did PHYSICIANS CHOICE SILICONE EAR PUTTY receive FDA 510(k) clearance?

PHYSICIANS CHOICE SILICONE EAR PUTTY received FDA 510(k) clearance on 1983-03-28, under 510(k) number K823921.

Who is the listed applicant for PHYSICIANS CHOICE SILICONE EAR PUTTY?

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 PHYSICIANS CHOICE SILICONE EAR PUTTY?

The FDA product code for PHYSICIANS CHOICE SILICONE EAR PUTTY is LDG.

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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 APPLICK821187MEDCO CUSTOM EAR PROTECTOR MOLD KITK812069BORES* DEPTH GAUGEK812071RK IV SURGICAL BLADESK812070BORES* ADJUSTABLE BLADE HOLDER

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Related Devices (Code: LDG)

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.

K792428COE-SILCoe Laboratories, 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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