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FDA 510(k)

PHILLY BOLT ADULT PROCEDURE KIT

K-Number: K823459 · 1982-12-22

ApplicantPhiladelphia Medical Specialties
Decision Date1982-12-22
Product CodeGWN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PHILLY BOLT ADULT PROCEDURE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Philadelphia Medical Specialties. It received FDA 510(k) clearance on 1982-12-22 under 510(k) number K823459. The device is classified under product code GWN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHILLY BOLT ADULT PROCEDURE KIT?

PHILLY BOLT ADULT PROCEDURE KIT is a medical device that received FDA 510(k) clearance on 1982-12-22. The listed applicant is Philadelphia Medical Specialties. The 510(k) number is K823459.

When did PHILLY BOLT ADULT PROCEDURE KIT receive FDA 510(k) clearance?

PHILLY BOLT ADULT PROCEDURE KIT received FDA 510(k) clearance on 1982-12-22, under 510(k) number K823459.

Who is the listed applicant for PHILLY BOLT ADULT PROCEDURE KIT?

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

What is the FDA product code for PHILLY BOLT ADULT PROCEDURE KIT?

The FDA product code for PHILLY BOLT ADULT PROCEDURE KIT is GWN.

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Other records listing Philadelphia Medical Specialties 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.

K840999PHILLY INFANT BOLTK834148PHILLY BOLTSK822636CLASS II DEVICE FOR I.C.P. MONITORINGK820151PHILLY INFANT BOLTK813440PHILLY BOLT

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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