The following data is part of a premarket notification filed by Molnlycke Healthcare, Us Llc with the FDA for Biogel Sensor Surgeon's Glove With Non-pyrogenic Statement.
| Device ID | K071700 |
| 510k Number | K071700 |
| Device Name: | BIOGEL SENSOR SURGEON'S GLOVE WITH NON-PYROGENIC STATEMENT |
| Classification | Surgeon's Gloves |
| Applicant | MOLNLYCKE HEALTHCARE, US LLC 5550 PEACHTREE PARKWAY SUITE 500 Norcross, GA 30092 |
| Contact | Steven Dowdley |
| Correspondent | Steven Dowdley MOLNLYCKE HEALTHCARE, US LLC 5550 PEACHTREE PARKWAY SUITE 500 Norcross, GA 30092 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-21 |
| Decision Date | 2007-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060097933969 | K071700 | 000 |
| 05060097932535 | K071700 | 000 |
| 05060097932542 | K071700 | 000 |
| 05060097932474 | K071700 | 000 |
| 05060097932481 | K071700 | 000 |
| 05060097932498 | K071700 | 000 |
| 05060097932504 | K071700 | 000 |
| 05060097932511 | K071700 | 000 |
| 05060097933815 | K071700 | 000 |
| 05060097933907 | K071700 | 000 |
| 05060097933914 | K071700 | 000 |
| 05060097933846 | K071700 | 000 |
| 05060097933853 | K071700 | 000 |
| 05060097933945 | K071700 | 000 |
| 05060097933877 | K071700 | 000 |
| 05060097932528 | K071700 | 000 |