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FDA 510(k)

BORES* ADJUSTABLE BLADE HOLDER

K-Number: K812070 · 1981-08-18

ApplicantSanta Barbara Medco, Inc.
Decision Date1981-08-18
Product CodeGDZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BORES* ADJUSTABLE BLADE HOLDER 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 1981-08-18 under 510(k) number K812070. The device is classified under product code GDZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BORES* ADJUSTABLE BLADE HOLDER?

BORES* ADJUSTABLE BLADE HOLDER is a medical device that received FDA 510(k) clearance on 1981-08-18. The listed applicant is Santa Barbara Medco, Inc.. The 510(k) number is K812070.

When did BORES* ADJUSTABLE BLADE HOLDER receive FDA 510(k) clearance?

BORES* ADJUSTABLE BLADE HOLDER received FDA 510(k) clearance on 1981-08-18, under 510(k) number K812070.

Who is the listed applicant for BORES* ADJUSTABLE BLADE HOLDER?

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 BORES* ADJUSTABLE BLADE HOLDER?

The FDA product code for BORES* ADJUSTABLE BLADE HOLDER is GDZ.

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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 PUTTYK821187MEDCO CUSTOM EAR PROTECTOR MOLD KITK812071RK IV SURGICAL BLADESK812069BORES* DEPTH GAUGE

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Related Devices (Code: GDZ)

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.

K091462SPECTRA MEDICAL SAFETY SCAPELSpectra, Inc.K890242SCALPEL HANDLEKinetic Medical ProductsK884512BEAVER(R) HANDLEBd Becton Dickinson Vacutainer Systems PreanalyticK863951P.S.I.-DISPOSABLE SCALPEL SURGEONS HANDLEPrecision Surgical Industries, Inc.K863808THE S. CORDERO STYLUSS. Cordero Co.K863212KEISEI HANDLES FOR SURGICAL BLADESKeisei Medical Industrial Co., Ltd.

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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