The following data is part of a premarket notification filed by Molnlycke Healthcare, Us Llc with the FDA for Biogel Orthopaedic Surgical Glove With Non-pryogenic Statement.
| Device ID | K071465 |
| 510k Number | K071465 |
| Device Name: | BIOGEL ORTHOPAEDIC SURGICAL GLOVE WITH NON-PRYOGENIC 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 | 2007-05-29 |
| Decision Date | 2007-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060097934171 | K071465 | 000 |
| 05060097934096 | K071465 | 000 |
| 05060097934157 | K071465 | 000 |
| 05060097934072 | K071465 | 000 |
| 05060097934133 | K071465 | 000 |
| 05060097934126 | K071465 | 000 |
| 05060097934041 | K071465 | 000 |