The following data is part of a premarket notification filed by Sinclair Pharmaceuticals, Ltd. with the FDA for Gelclair Concentrated Oral Gel.
Device ID | K013056 |
510k Number | K013056 |
Device Name: | GELCLAIR CONCENTRATED ORAL GEL |
Classification | Dressing, Wound, Drug |
Applicant | SINCLAIR PHARMACEUTICALS, LTD. 1 ALDER BROOK Chinley, High Peak, GB Sk23 6dn |
Contact | Priscilla Cox |
Correspondent | Priscilla Cox SINCLAIR PHARMACEUTICALS, LTD. 1 ALDER BROOK Chinley, High Peak, GB Sk23 6dn |
Product Code | FRO |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-09-11 |
Decision Date | 2001-12-21 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00370564456156 | K013056 | 000 |