510(k) K904195
K904195 is an FDA 510(k) premarket notification submitted by Bp , Ltd. for the device "DISPOSABLE FACE MASK". The FDA issued a decision of Substantially Equivalent on September 25, 1990. The device falls under product code BYG (Mask, Oxygen), a Class I device regulated under 21 CFR 868.5580. Bp , Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 25, 1990
- Date Received
- September 12, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mask, Oxygen
- Device Class
- Class I
- Regulation Number
- 868.5580
- Review Panel
- AN
- Submission Type