The following data is part of a premarket notification filed by Mapa Gmbh with the FDA for Billy Boy Male Latex Condom.
Device ID | K111093 |
510k Number | K111093 |
Device Name: | BILLY BOY MALE LATEX CONDOM |
Classification | Condom |
Applicant | MAPA GMBH INDUSTRIESTRASSE 21-25 Zeven, DE 27404 |
Contact | German Frank |
Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
Product Code | HIS |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2011-04-19 |
Decision Date | 2011-06-03 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00850002174540 | K111093 | 000 |
00850002174533 | K111093 | 000 |