The following data is part of a premarket notification filed by Hsiner Co., Ltd. with the FDA for Nippv Silicone Face Mask, Nippv Economy Face Mask, Nippv Silicone Nasal Mask Model 10212, 10222, 10202.
| Device ID | K102120 |
| 510k Number | K102120 |
| Device Name: | NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | HSINER CO., LTD. 29201 VIA NORTE Temecula, CA 92591 |
| Contact | Tom Shanks |
| Correspondent | Tom Shanks HSINER CO., LTD. 29201 VIA NORTE Temecula, CA 92591 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-29 |
| Decision Date | 2011-08-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04712688051286 | K102120 | 000 |
| 10193489021547 | K102120 | 000 |
| 50190752139471 | K102120 | 000 |
| 50190752139464 | K102120 | 000 |
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| 50190752139426 | K102120 | 000 |
| 50190752139389 | K102120 | 000 |
| 50190752139372 | K102120 | 000 |
| 50190752139365 | K102120 | 000 |
| 20193489021513 | K102120 | 000 |
| 20193489021476 | K102120 | 000 |
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| 20193489021506 | K102120 | 000 |
| 20193489021490 | K102120 | 000 |
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| 20193489024651 | K102120 | 000 |
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| 20193489021520 | K102120 | 000 |
| 20193489021469 | K102120 | 000 |
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| 20193489021421 | K102120 | 000 |
| 20193489021407 | K102120 | 000 |
| 20193489021483 | K102120 | 000 |