The following data is part of a premarket notification filed by Shanghai Gangkai Purifying Products Co., Ltd. with the FDA for Shanghai Ganghai Model Giko 1400.
| Device ID | K063334 |
| 510k Number | K063334 |
| Device Name: | SHANGHAI GANGHAI MODEL GIKO 1400 |
| Classification | Respirator, Surgical |
| Applicant | SHANGHAI GANGKAI PURIFYING PRODUCTS CO., LTD. 7380 36TH COURT Vero Beach, FL 32967 |
| Contact | Joseph Z Zdrok |
| Correspondent | Joseph Z Zdrok SHANGHAI GANGKAI PURIFYING PRODUCTS CO., LTD. 7380 36TH COURT Vero Beach, FL 32967 |
| Product Code | MSH |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-06 |
| Decision Date | 2006-12-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06946276000013 | K063334 | 000 |