510(k) K780743
K780743 is an FDA 510(k) premarket notification submitted by Hygienic Dental Mfg., Co., The for the device "CLAMP FORCEPS". The FDA issued a decision of Substantially Equivalent on May 12, 1978. The device falls under product code EJG (Forceps, Rubber Dam Clamp), a Class I device regulated under 21 CFR 872.6300. Hygienic Dental Mfg., Co., The has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 12, 1978
- Date Received
- April 13, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Forceps, Rubber Dam Clamp
- Device Class
- Class I
- Regulation Number
- 872.6300
- Review Panel
- DE
- Submission Type