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FDA 510(k)

OTOSCOPE SPECULA

K-Number: K780723 · 1978-05-09

ApplicantAbco Dealers, Inc.
Decision Date1978-05-09
Product CodeEPY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OTOSCOPE SPECULA is the device name listed in this FDA 510(k) record. The listed applicant is Abco Dealers, Inc.. It received FDA 510(k) clearance on 1978-05-09 under 510(k) number K780723. The device is classified under product code EPY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OTOSCOPE SPECULA?

OTOSCOPE SPECULA is a medical device that received FDA 510(k) clearance on 1978-05-09. The listed applicant is Abco Dealers, Inc.. The 510(k) number is K780723.

When did OTOSCOPE SPECULA receive FDA 510(k) clearance?

OTOSCOPE SPECULA received FDA 510(k) clearance on 1978-05-09, under 510(k) number K780723.

Who is the listed applicant for OTOSCOPE SPECULA?

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

What is the FDA product code for OTOSCOPE SPECULA?

The FDA product code for OTOSCOPE SPECULA is EPY.

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Other records listing Abco Dealers, 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.

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Related Devices (Code: EPY)

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.

K950086PEDIA PALS, INCORPORATEDPedia Pals, Inc.K925754ECONOMRudolf Riester GmbH & Co. KGK853588FIBRELIGHT NASAL SPECULADowns Surgical , Ltd.K834189JAKOBI SURG. INSTRUMENTS #7 44/47Imm Enterprises , Ltd.K822370UNIVERSAL SPECULUM HOLDERTreace Medical, Inc.K822373EAR SURGERY SPECULUMTreace Medical, 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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