510(k) K853573
K853573 is an FDA 510(k) premarket notification submitted by Medipart Jerry Alexander for the device "MEDIPART FACE MASK HEADSTRAP MP-9100". The FDA issued a decision of Substantially Equivalent on October 29, 1985. The device falls under product code BTK (Strap, Head, Gas Mask), a Class I device regulated under 21 CFR 868.5560. Medipart Jerry Alexander has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 29, 1985
- Date Received
- August 26, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Strap, Head, Gas Mask
- Device Class
- Class I
- Regulation Number
- 868.5560
- Review Panel
- AN
- Submission Type