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FDA 510(k)

CAMLOC SYRINGE BIOPSY KIT

K-Number: K801304 · 1980-06-17

ApplicantJohannah Medical Services, Inc.
Decision Date1980-06-17
Product CodeGEE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CAMLOC SYRINGE BIOPSY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Johannah Medical Services, Inc.. It received FDA 510(k) clearance on 1980-06-17 under 510(k) number K801304. The device is classified under product code GEE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAMLOC SYRINGE BIOPSY KIT?

CAMLOC SYRINGE BIOPSY KIT is a medical device that received FDA 510(k) clearance on 1980-06-17. The listed applicant is Johannah Medical Services, Inc.. The 510(k) number is K801304.

When did CAMLOC SYRINGE BIOPSY KIT receive FDA 510(k) clearance?

CAMLOC SYRINGE BIOPSY KIT received FDA 510(k) clearance on 1980-06-17, under 510(k) number K801304.

Who is the listed applicant for CAMLOC SYRINGE BIOPSY KIT?

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

What is the FDA product code for CAMLOC SYRINGE BIOPSY KIT?

The FDA product code for CAMLOC SYRINGE BIOPSY KIT is GEE.

Related Clinical Trials

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Other records listing Johannah Medical Services, 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.

K791643BONE MARROW NEEDLEK771108NEEDLE, CHIBA UNIVERSITYK770370CONVENIENCE TRAY

Related Devices (Code: GEE)

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.

K854003STERILE SOFT TISSUE BIOPSY NEEDLECo-Medical, Inc.K841008BIOPSY PUNCH, VARIOUSPremier Dental Products Co.K822490DEFLECTING CYTOLOGY BRUSHVan-Tec, Inc.K820259STERILE CYTOLOGY BRUSHESAmerican Endoscopy, Inc.K812694WHISK-RMedi-SpecK792316TROTEX II SCREW NEEDLE BIOPSY INSTR. SETUrsus Konsult AB

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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