The following data is part of a premarket notification filed by Pediatric Pharmaceuticals Inc. with the FDA for Colonglide Lubricant.
| Device ID | K141028 |
| 510k Number | K141028 |
| Device Name: | COLONGLIDE LUBRICANT |
| Classification | Lubricant, Patient |
| Applicant | PEDIATRIC PHARMACEUTICALS INC. 2137 ROUTE 35 Holmdel, NJ 07733 |
| Contact | Robert M Harris |
| Correspondent | Robert M Harris PEDIATRIC PHARMACEUTICALS INC. 2137 ROUTE 35 Holmdel, NJ 07733 |
| Product Code | KMJ |
| CFR Regulation Number | 880.6375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-22 |
| Decision Date | 2014-07-24 |