510(k) K771522
K771522 is an FDA 510(k) premarket notification submitted by Premier Dental Products Co. for the device "FORCEPS, STYLE #849". The FDA issued a decision of Substantially Equivalent on August 16, 1977. The device falls under product code EMH (Forceps, Rongeur, Surgical), a Class I device regulated under 21 CFR 872.4565. Premier Dental Products Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 16, 1977
- Date Received
- August 8, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Forceps, Rongeur, Surgical
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type