510(k) K770407
K770407 is an FDA 510(k) premarket notification submitted by Worldwide Dental, Inc. for the device "SHIELD, DENTAL X-RAY, PROTECTIVE". The FDA issued a decision of Substantially Equivalent on March 15, 1977. The device falls under product code IWO (Apron, Protective), a Class I device regulated under 21 CFR 892.6500. Worldwide Dental, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 15, 1977
- Date Received
- March 4, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apron, Protective
- Device Class
- Class I
- Regulation Number
- 892.6500
- Review Panel
- RA
- Submission Type