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FDA 510(k)

BARRAQUER OVAL SPECULUM-VARIOUS SIZES

K-Number: K772370 · 1978-01-17

ApplicantEdward Weck, Inc.
Decision Date1978-01-17
Product CodeEPY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BARRAQUER OVAL SPECULUM-VARIOUS SIZES is the device name listed in this FDA 510(k) record. The listed applicant is Edward Weck, Inc.. It received FDA 510(k) clearance on 1978-01-17 under 510(k) number K772370. 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 BARRAQUER OVAL SPECULUM-VARIOUS SIZES?

BARRAQUER OVAL SPECULUM-VARIOUS SIZES is a medical device that received FDA 510(k) clearance on 1978-01-17. The listed applicant is Edward Weck, Inc.. The 510(k) number is K772370.

When did BARRAQUER OVAL SPECULUM-VARIOUS SIZES receive FDA 510(k) clearance?

BARRAQUER OVAL SPECULUM-VARIOUS SIZES received FDA 510(k) clearance on 1978-01-17, under 510(k) number K772370.

Who is the listed applicant for BARRAQUER OVAL SPECULUM-VARIOUS SIZES?

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

What is the FDA product code for BARRAQUER OVAL SPECULUM-VARIOUS SIZES?

The FDA product code for BARRAQUER OVAL SPECULUM-VARIOUS SIZES is EPY.

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Other records listing Edward Weck, 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.

K915378WECK TROCARK914690LM15(TM), CATALOG NUMBER - 523821K911915HEMOCLIP IIK914470PNEUMO-SEAL(TM)K911272ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705K902108HEM-O-LOK(TM)

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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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