The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Monoject(r) Snap-over Safety Cap.
| Device ID | K882614 |
| 510k Number | K882614 |
| Device Name: | MONOJECT(R) SNAP-OVER SAFETY CAP |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
| Contact | Cynthia Pestka |
| Correspondent | Cynthia Pestka SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-24 |
| Decision Date | 1988-08-09 |