The following data is part of a premarket notification filed by Angeline Group Ltd. with the FDA for Surgical Face Mask; Surgical Face Mask.
Device ID | K110027 |
510k Number | K110027 |
Device Name: | SURGICAL FACE MASK; SURGICAL FACE MASK |
Classification | Mask, Surgical |
Applicant | ANGELINE GROUP LTD. NO.45, MINSHENG RD DANSHUI TOWN Taipei County, TW 251 |
Contact | Michael Lee |
Correspondent | Michael Lee ANGELINE GROUP LTD. NO.45, MINSHENG RD DANSHUI TOWN Taipei County, TW 251 |
Product Code | FXX |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-01-05 |
Decision Date | 2011-08-05 |
Summary: | summary |