510(k) K874543
K874543 is an FDA 510(k) premarket notification submitted by Allergan, Inc. for the device "MODEL OPO-32 IRRIGATION SLEEVE". The FDA issued a decision of Substantially Equivalent on January 14, 1988. The device falls under product code EIB (Syringe, Irrigating (Dental)), a Class I device regulated under 21 CFR 872.4565. Allergan, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 14, 1988
- Date Received
- November 3, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Syringe, Irrigating (Dental)
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type