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 |