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 |