FDA 510(k) K911422, DRUG NEBULIZERS, by Intersurgical, Inc.
FDA 510(k) K911422, DRUG NEBULIZERS, by Intersurgical, Inc.
Device Classification Name: Nebulizer (Direct Patient Interface)
510(k) Number: K911422
Device Name: DRUG NEBULIZERS
Applicant: Intersurgical, Inc.
Regulation Number: 868.5630
Classification Product Code: CAF
Date Received: 02/05/1991
Decision Date: 10/23/1991
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
510k Review Panel: Anesthesiology
Total number of pages: 188
Fully redacted pages: 71
Content pages: 117
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