The following data is part of a premarket notification filed by Premium Plus International Limited with the FDA for Premium Plus Disposable Barrier Sleeve.
| Device ID | K163447 |
| 510k Number | K163447 |
| Device Name: | Premium Plus Disposable Barrier Sleeve |
| Classification | Dental Barriers And Sleeves |
| Applicant | PREMIUM PLUS INTERNATIONAL LIMITED FLAT 1001 YUEN LONG TRADING CENTRE, 33 WANG YIP STREET WEST YUEN LONG N.T. Hong Kong, CN |
| Contact | Jessica Mao |
| Correspondent | Jessica Mao PREMIUM PLUS INTERNATIONAL LIMITED FLAT 1001 YUEN LONG TRADING CENTRE, 33 WANG YIP STREET WEST YUEN LONG N.T. Hong Kong, CN |
| Product Code | PEM |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-08 |
| Decision Date | 2017-06-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D89260705533180 | K163447 | 000 |
| D8381098 | K163447 | 000 |
| D8381118 | K163447 | 000 |
| D8381128 | K163447 | 000 |
| D8381138 | K163447 | 000 |
| D8381148 | K163447 | 000 |
| D8381188 | K163447 | 000 |
| D8381198 | K163447 | 000 |
| D8381218 | K163447 | 000 |
| D838123L8 | K163447 | 000 |
| D838123S8 | K163447 | 000 |
| D838123SS8 | K163447 | 000 |
| D838123XL8 | K163447 | 000 |
| D8381258 | K163447 | 000 |
| D838125SS8 | K163447 | 000 |
| D8381288 | K163447 | 000 |
| D8381298 | K163447 | 000 |
| D8381088 | K163447 | 000 |
| D8381078 | K163447 | 000 |
| D89260705533190 | K163447 | 000 |
| D89260705533600 | K163447 | 000 |
| D89260705533610 | K163447 | 000 |
| D89260705533620 | K163447 | 000 |
| D89260705533650 | K163447 | 000 |
| D89260705533660 | K163447 | 000 |
| D89260705533670 | K163447 | 000 |
| D838100B8 | K163447 | 000 |
| D838100C8 | K163447 | 000 |
| D8381018 | K163447 | 000 |
| D8381028 | K163447 | 000 |
| D8381038 | K163447 | 000 |
| D838104L8 | K163447 | 000 |
| D838104S8 | K163447 | 000 |
| D8381058 | K163447 | 000 |
| D8381068 | K163447 | 000 |
| D8381338 | K163447 | 000 |
| D838135L8 | K163447 | 000 |
| D838135S8 | K163447 | 000 |
| D83818928 | K163447 | 000 |
| D8381908 | K163447 | 000 |
| D83819808 | K163447 | 000 |
| D83819818 | K163447 | 000 |
| D83819828 | K163447 | 000 |
| D8381982B8 | K163447 | 000 |
| D83819908 | K163447 | 000 |
| D83819918 | K163447 | 000 |
| D83819928 | K163447 | 000 |
| D8388008B8 | K163447 | 000 |
| D8388008C8 | K163447 | 000 |
| D838BC123SS8 | K163447 | 000 |
| D838BC125SS8 | K163447 | 000 |
| D838PS140L8 | K163447 | 000 |
| D838PS140M8 | K163447 | 000 |
| D838PS140S8 | K163447 | 000 |
| D83818918 | K163447 | 000 |
| D83818908 | K163447 | 000 |
| D8381368 | K163447 | 000 |
| D8381388 | K163447 | 000 |
| D838140L8 | K163447 | 000 |
| D838140M8 | K163447 | 000 |
| D838140S8 | K163447 | 000 |
| D838140XS8 | K163447 | 000 |
| D8381458 | K163447 | 000 |
| D8381588 | K163447 | 000 |
| D83818318 | K163447 | 000 |
| D83818328 | K163447 | 000 |
| D83818808 | K163447 | 000 |
| D83818818 | K163447 | 000 |
| D83818828 | K163447 | 000 |
| D8381882B8 | K163447 | 000 |
| D83818838 | K163447 | 000 |
| D83818848 | K163447 | 000 |
| D838PS140XS8 | K163447 | 000 |