• FDA DYMISTA NDA 202236 approval records — 22 FDA documents, 848 pages
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FDA 510(k) K820227, STER-O-DOSE, by Inhalation Therapy Equipment, Co.

FDA 510(k) K820227, STER-O-DOSE, by Inhalation Therapy Equipment, Co.

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510(K) Number: K820227
Device Name: STER-O-DOSE
Manufacturer: Inhalation Therapy Equipment, Co.
Device Classification Name: nebulizer (direct patient interface)
Regulation Number: 868.5630
Classification Product Code: CAF
Date Received: 01/27/1982
Decision Date: 02/23/1982
Regulation Medical Specialty: Anesthesiology

Total pages: 26
Fully redacted pages: 9
Content pages: 17
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