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FDA 510(k)

RK IV SURGICAL BLADES

K-Number: K812071 · 1981-08-31

ApplicantSanta Barbara Medco, Inc.
Decision Date1981-08-31
Product CodeGES
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RK IV SURGICAL BLADES 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 1981-08-31 under 510(k) number K812071. The device is classified under product code GES. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RK IV SURGICAL BLADES?

RK IV SURGICAL BLADES is a medical device that received FDA 510(k) clearance on 1981-08-31. The listed applicant is Santa Barbara Medco, Inc.. The 510(k) number is K812071.

When did RK IV SURGICAL BLADES receive FDA 510(k) clearance?

RK IV SURGICAL BLADES received FDA 510(k) clearance on 1981-08-31, under 510(k) number K812071.

Who is the listed applicant for RK IV SURGICAL BLADES?

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 RK IV SURGICAL BLADES?

The FDA product code for RK IV SURGICAL BLADES is GES.

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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 KITK812069BORES* DEPTH GAUGEK812070BORES* ADJUSTABLE BLADE HOLDER

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Related Devices (Code: GES)

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.

K032242PERSONNA PLUS SAFETY SCALPEL SYSTEMOmi Manufacturing Pty., Ltd.K932998EASY-ONDevon Industries, Inc.K923170LOS ALAMOS RETRACTABLE KNIFEInnovative Surgical Technology, Inc.K915119SCALPEL BLADE REMOVER (BLADEGARD)Intergrated Visual, Inc.K911913PRECISION GLIDE - ENHANCED SURGICAL BLADEBd Becton Dickinson Vacutainer Systems PreanalyticK900266STERILE CARBON STEEL SURGICAL BLADERahn Laboratories

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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