510(k) K853005
K853005 is an FDA 510(k) premarket notification submitted by The S. S. White Co. for the device "S.S. WHITE DENTAL X-RAY FILM HOLDER & ALIGNING ARM". The FDA issued a decision of Substantially Equivalent on August 13, 1985. The device falls under product code EGZ (Holder, Film, X-Ray), a Class I device regulated under 21 CFR 872.1905. The S. S. White Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 13, 1985
- Date Received
- July 16, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Holder, Film, X-Ray
- Device Class
- Class I
- Regulation Number
- 872.1905
- Review Panel
- DE
- Submission Type