The following data is part of a premarket notification filed by Pharma-plast, Ltd. with the FDA for Steriseal Ophthalmic Cannula.
| Device ID | K943932 |
| 510k Number | K943932 |
| Device Name: | STERISEAL OPHTHALMIC CANNULA |
| Classification | Cannula, Ophthalmic |
| Applicant | PHARMA-PLAST, LTD. STERISEAL DIVISION THORNHILL RD. NORTH MOONS MOAT Redditch, Worcestershire, GB B98 9nl |
| Contact | A.p. Pratt |
| Correspondent | A.p. Pratt PHARMA-PLAST, LTD. STERISEAL DIVISION THORNHILL RD. NORTH MOONS MOAT Redditch, Worcestershire, GB B98 9nl |
| Product Code | HMX |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-12 |
| Decision Date | 1995-01-18 |