The following data is part of a premarket notification filed by Daryl C. Fallas with the FDA for Lip Grip Cap Holder.
| Device ID | K935916 |
| 510k Number | K935916 |
| Device Name: | LIP GRIP CAP HOLDER |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | DARYL C. FALLAS P.O. BOX 123 77 PARKER AVENUE Deal, NJ 07723 |
| Contact | Daryl Fallas |
| Correspondent | Daryl Fallas DARYL C. FALLAS P.O. BOX 123 77 PARKER AVENUE Deal, NJ 07723 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-09 |
| Decision Date | 1995-11-03 |