510(k) K894759
K894759 is an FDA 510(k) premarket notification submitted by Barrier Concepts, Inc. for the device "ALLPAC(TM) MATERIAL". The FDA issued a decision of Substantially Equivalent on October 13, 1989. The device falls under product code EIA (Unit, Operative Dental), a Class I device regulated under 21 CFR 872.6640. Barrier Concepts, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 13, 1989
- Date Received
- July 27, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Operative Dental
- Device Class
- Class I
- Regulation Number
- 872.6640
- Review Panel
- DE
- Submission Type