The following data is part of a premarket notification filed by Line One Laboratories, Inc. with the FDA for Trust Dam.
Device ID | K091769 |
510k Number | K091769 |
Device Name: | TRUST DAM |
Classification | Barrier, Std, Oral Sex |
Applicant | LINE ONE LABORATORIES, INC. PO BOX 12139 Durham, NC 27709 |
Contact | Eli J Carter |
Correspondent | Eli J Carter LINE ONE LABORATORIES, INC. PO BOX 12139 Durham, NC 27709 |
Product Code | MSC |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-06-16 |
Decision Date | 2010-02-05 |
Summary: | summary |