510(k) K881707
K881707 is an FDA 510(k) premarket notification submitted by B&B Medical Assoc., Inc. for the device "INTROCULAR FLUID INJECTOR". The FDA issued a decision of Substantially Equivalent on October 21, 1988. The device falls under product code FIH (Pump, Infusion Or Syringe, Extra-Luminal), a Class II device regulated under 21 CFR 876.5820. B&B Medical Assoc., Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 21, 1988
- Date Received
- April 11, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Infusion Or Syringe, Extra-Luminal
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type