The following data is part of a premarket notification filed by Dr. F. Ross Sharp Ltd. with the FDA for Inviro Syringe.
| Device ID | K941450 |
| 510k Number | K941450 |
| Device Name: | INVIRO SYRINGE |
| Classification | Syringe, Antistick |
| Applicant | DR. F. ROSS SHARP LTD. 1188 THURLOW ST. VANCOUVER, B.C. V6E 1X3 Canada, CA |
| Contact | F. R Sharp |
| Correspondent | F. R Sharp DR. F. ROSS SHARP LTD. 1188 THURLOW ST. VANCOUVER, B.C. V6E 1X3 Canada, CA |
| Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-24 |
| Decision Date | 1994-12-12 |