The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Cooper Surg Aspiration Cannula/custom Conven Paks.
| Device ID | K872214 |
| 510k Number | K872214 |
| Device Name: | COOPER SURG ASPIRATION CANNULA/CUSTOM CONVEN PAKS |
| Classification | Cannula, Surgical, General & Plastic Surgery |
| Applicant | COOPERVISION, INC. 17701 COWAN AVE.P. O. BOX 19587 Irvine, CA 92713 |
| Contact | David W Drapf |
| Correspondent | David W Drapf COOPERVISION, INC. 17701 COWAN AVE.P. O. BOX 19587 Irvine, CA 92713 |
| Product Code | GEA |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-09 |
| Decision Date | 1987-08-17 |