510(k) K950259
K950259 is an FDA 510(k) premarket notification submitted by Dr. Joseph E. Grasso, D.D.S. for the device "COUPLING DEVICE FOR DENTAL PROSTHESIS". The FDA issued a decision of Substantially Equivalent on December 6, 1996. The device falls under product code EGG (Attachment, Precision, All), a Class I device regulated under 21 CFR 872.3165. Dr. Joseph E. Grasso, D.D.S. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 6, 1996
- Date Received
- January 23, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Attachment, Precision, All
- Device Class
- Class I
- Regulation Number
- 872.3165
- Review Panel
- DE
- Submission Type