The following data is part of a premarket notification filed by Thai Disposable Products Co., Ltd. with the FDA for Surgical Cap.
Device ID | K954556 |
510k Number | K954556 |
Device Name: | SURGICAL CAP |
Classification | Cap, Surgical |
Applicant | THAI DISPOSABLE PRODUCTS CO., LTD. SUKHUMVIT ROAD (SOI 117) BANG MUANG MAI, MUANG DISTRICT Samutprakaran, TH 10270 |
Contact | Thawatchai Maturaporn |
Correspondent | Thawatchai Maturaporn THAI DISPOSABLE PRODUCTS CO., LTD. SUKHUMVIT ROAD (SOI 117) BANG MUANG MAI, MUANG DISTRICT Samutprakaran, TH 10270 |
Product Code | FYF |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-10-02 |
Decision Date | 1996-03-12 |