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FDA 510(k)

SEA-LONG MEDICAL TREATMENT HOOD

K-Number: K010659 · 2001-05-16

ApplicantSea-Long Medical Systems, Inc.
Decision Date2001-05-16
Product CodeCBF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SEA-LONG MEDICAL TREATMENT HOOD is the device name listed in this FDA 510(k) record. The listed applicant is Sea-Long Medical Systems, Inc.. It received FDA 510(k) clearance on 2001-05-16 under 510(k) number K010659. The device is classified under product code CBF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEA-LONG MEDICAL TREATMENT HOOD?

SEA-LONG MEDICAL TREATMENT HOOD is a medical device that received FDA 510(k) clearance on 2001-05-16. The listed applicant is Sea-Long Medical Systems, Inc.. The 510(k) number is K010659.

When did SEA-LONG MEDICAL TREATMENT HOOD receive FDA 510(k) clearance?

SEA-LONG MEDICAL TREATMENT HOOD received FDA 510(k) clearance on 2001-05-16, under 510(k) number K010659.

Who is the listed applicant for SEA-LONG MEDICAL TREATMENT HOOD?

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

What is the FDA product code for SEA-LONG MEDICAL TREATMENT HOOD?

The FDA product code for SEA-LONG MEDICAL TREATMENT HOOD is CBF.

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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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