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FDA 510(k)

SURGICAL CAP CALOT

K-Number: K851558 · 1985-04-30

ApplicantRoseburg SA
Decision Date1985-04-30
Product CodeFYF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL CAP CALOT is the device name listed in this FDA 510(k) record. The listed applicant is Roseburg SA. It received FDA 510(k) clearance on 1985-04-30 under 510(k) number K851558. The device is classified under product code FYF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL CAP CALOT?

SURGICAL CAP CALOT is a medical device that received FDA 510(k) clearance on 1985-04-30. The listed applicant is Roseburg SA. The 510(k) number is K851558.

When did SURGICAL CAP CALOT receive FDA 510(k) clearance?

SURGICAL CAP CALOT received FDA 510(k) clearance on 1985-04-30, under 510(k) number K851558.

Who is the listed applicant for SURGICAL CAP CALOT?

The FDA 510(k) record lists Roseburg SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGICAL CAP CALOT?

The FDA product code for SURGICAL CAP CALOT is FYF.

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Other records listing Roseburg SA 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.

K931155STAPLE, FIXATION BONE; SCREW FIXATION BONEK890081CALIUS-ISABEL CANOVAS SUNGLASSESK885275ASSENAT-BLESCHET SUNGLASSESK882392BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVESK872715UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERYK874317POIRIER KID-ROLLER MANUAL WHEELCHAIR

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Related Devices (Code: FYF)

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.

K972227SHOE COVERAmerican Seal Co.K955833NIOMED SURGICAL CAPSAmerasia Corp.K954556SURGICAL CAPThai Disposable Products Co., Ltd.K954454NIOMED SURGICAL HOODAmerasia Corp.K954455NIOMED BOUFFANT CAPSAmerasia Corp.K953878BOUFFANT CAPAmerican Threshold Industries, 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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