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FDA 510(k)

SENTRY BREAKWAY NECK STRAP

K-Number: K862538 · 1986-07-11

ApplicantOrmco Corp.
Decision Date1986-07-11
Product CodeDZB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SENTRY BREAKWAY NECK STRAP is the device name listed in this FDA 510(k) record. The listed applicant is Ormco Corp.. It received FDA 510(k) clearance on 1986-07-11 under 510(k) number K862538. The device is classified under product code DZB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SENTRY BREAKWAY NECK STRAP?

SENTRY BREAKWAY NECK STRAP is a medical device that received FDA 510(k) clearance on 1986-07-11. The listed applicant is Ormco Corp.. The 510(k) number is K862538.

When did SENTRY BREAKWAY NECK STRAP receive FDA 510(k) clearance?

SENTRY BREAKWAY NECK STRAP received FDA 510(k) clearance on 1986-07-11, under 510(k) number K862538.

Who is the listed applicant for SENTRY BREAKWAY NECK STRAP?

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

What is the FDA product code for SENTRY BREAKWAY NECK STRAP?

The FDA product code for SENTRY BREAKWAY NECK STRAP is DZB.

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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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