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FDA 510(k)

SEA-LONG NECKSEAL & HOOD

K-Number: K852345 · 1985-06-20

ApplicantSafety Sea Systems, Inc.
Decision Date1985-06-20
Product CodeBYL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SEA-LONG NECKSEAL & HOOD is the device name listed in this FDA 510(k) record. The listed applicant is Safety Sea Systems, Inc.. It received FDA 510(k) clearance on 1985-06-20 under 510(k) number K852345. The device is classified under product code BYL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEA-LONG NECKSEAL & HOOD?

SEA-LONG NECKSEAL & HOOD is a medical device that received FDA 510(k) clearance on 1985-06-20. The listed applicant is Safety Sea Systems, Inc.. The 510(k) number is K852345.

When did SEA-LONG NECKSEAL & HOOD receive FDA 510(k) clearance?

SEA-LONG NECKSEAL & HOOD received FDA 510(k) clearance on 1985-06-20, under 510(k) number K852345.

Who is the listed applicant for SEA-LONG NECKSEAL & HOOD?

The FDA 510(k) record lists Safety Sea Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SEA-LONG NECKSEAL & HOOD?

The FDA product code for SEA-LONG NECKSEAL & HOOD is BYL.

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Related Devices (Code: BYL)

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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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