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 |