The following data is part of a premarket notification filed by Ballard Medical Products with the FDA for Safety Shield Kit.
| Device ID | K873731 |
| 510k Number | K873731 |
| Device Name: | SAFETY SHIELD KIT |
| Classification | Mask, Surgical |
| Applicant | BALLARD MEDICAL PRODUCTS 2101 L STREET, N.W. Washington, DC 20037 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein BALLARD MEDICAL PRODUCTS 2101 L STREET, N.W. Washington, DC 20037 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-10 |
| Decision Date | 1988-01-15 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SAFETY SHIELD KIT 73686544 1491006 Dead/Cancelled |
BALLARD MEDICAL PRODUCTS 1987-09-28 |