The following data is part of a premarket notification filed by Molnlycke Health Care Us, Llc with the FDA for Biogel Indicator Underglove With Non-pyrogenic Statement.
| Device ID | K071565 |
| 510k Number | K071565 |
| Device Name: | BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENT |
| Classification | Surgeon's Gloves |
| Applicant | MOLNLYCKE HEALTH CARE US, LLC 5550 PEACHTREE PARKWAY SUITE 500 Norcross, GA 30092 |
| Contact | Steven Dowdley |
| Correspondent | Steven Dowdley MOLNLYCKE HEALTH CARE 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 | 2007-06-07 |
| Decision Date | 2007-09-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07323190093045 | K071565 | 000 |
| 07323190093021 | K071565 | 000 |
| 07323190092994 | K071565 | 000 |
| 07323190092956 | K071565 | 000 |
| 07323190092918 | K071565 | 000 |
| 07323190092697 | K071565 | 000 |
| 07323190085484 | K071565 | 000 |
| 07323190085453 | K071565 | 000 |