Submission Details
| 510(k) Number | K952689 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 12, 1995 |
| Decision Date | July 11, 1995 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
Cleared
Traditional
BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK
Jul 1995
Decision
29d
Days
Class 1
Risk
About This 510(k) Submission
K952689 is an FDA 510(k) clearance for the BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK, a Mask, Gas, Anesthetic (Class I — General Controls, product code BSJ), submitted by Owens-Brigam Medical Co. (Newland, US). The FDA issued a Cleared decision on July 11, 1995, 29 days after receiving the submission on June 12, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5550.
Device Classification
| Product Code | BSJ — Mask, Gas, Anesthetic |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 868.5550 |
Manufacturer
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