The following data is part of a premarket notification filed by Glyde Usa, Inc. with the FDA for Glyde Dam Lollyes.
| Device ID | K970577 |
| 510k Number | K970577 |
| Device Name: | GLYDE DAM LOLLYES |
| Classification | Barrier, Std, Oral Sex |
| Applicant | GLYDE USA, INC. 14808 N.E. 66TH ST. Remond, WA 98052 -4712 |
| Contact | Louise C Myers |
| Correspondent | Louise C Myers GLYDE USA, INC. 14808 N.E. 66TH ST. Remond, WA 98052 -4712 |
| Product Code | MSC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-14 |
| Decision Date | 1998-01-08 |
| Summary: | summary |