The following data is part of a premarket notification filed by Innovative Outsourcing Solutions with the FDA for Sts Shield With Mask.
| Device ID | K961402 |
| 510k Number | K961402 |
| Device Name: | STS SHIELD WITH MASK |
| Classification | Mask, Surgical |
| Applicant | INNOVATIVE OUTSOURCING SOLUTIONS 51 MIDDLESEX ST. North Chelmsford, MA 01863 |
| Contact | Lawrence A Rucki |
| Correspondent | Lawrence A Rucki INNOVATIVE OUTSOURCING SOLUTIONS 51 MIDDLESEX ST. North Chelmsford, MA 01863 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-11 |
| Decision Date | 1996-07-12 |