510(k) K833229
K833229 is an FDA 510(k) premarket notification submitted by H & M Douglas Enterprises, Inc. for the device "SUN BED BY VERRE ET QUARTZ UVA-FRANCE". The FDA issued a decision of Substantially Equivalent on January 27, 1984. The device falls under product code FTZ (Locator, Magnetic), a Class I device regulated under 21 CFR 886.4445.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 27, 1984
- Date Received
- August 24, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Locator, Magnetic
- Device Class
- Class I
- Regulation Number
- 886.4445
- Review Panel
- OP
- Submission Type