The following data is part of a premarket notification filed by Stackhouse Assoc. with the FDA for Anti-infection Shield.
Device ID | K872935 |
510k Number | K872935 |
Device Name: | ANTI-INFECTION SHIELD |
Classification | Mask, Surgical |
Applicant | STACKHOUSE ASSOC. 150 SIERRA ST. El Segundo, CA 90245 |
Contact | W. H Stackhouse |
Correspondent | W. H Stackhouse STACKHOUSE ASSOC. 150 SIERRA ST. El Segundo, CA 90245 |
Product Code | FXX |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-27 |
Decision Date | 1987-11-09 |