The following data is part of a premarket notification filed by B&b Medical Assoc., Inc. with the FDA for Introcular Fluid Injector.
| Device ID | K881707 |
| 510k Number | K881707 |
| Device Name: | INTROCULAR FLUID INJECTOR |
| Classification | Pump, Infusion Or Syringe, Extra-luminal |
| Applicant | B&B MEDICAL ASSOC., INC. 4 CANAL ST. Danvers, MA 01923 |
| Contact | Alden C Bertrand |
| Correspondent | Alden C Bertrand B&B MEDICAL ASSOC., INC. 4 CANAL ST. Danvers, MA 01923 |
| Product Code | FIH |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-11 |
| Decision Date | 1988-10-21 |