The following data is part of a premarket notification filed by Sinclair Pharmaceuticals, Ltd. with the FDA for Aloclair Oral Spray.
Device ID | K042722 |
510k Number | K042722 |
Device Name: | ALOCLAIR ORAL SPRAY |
Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
Applicant | SINCLAIR PHARMACEUTICALS, LTD. BOROUGH RD. Godalming, Surrey, GB Gu7 2ab |
Contact | Michael Killeen |
Correspondent | Michael Killeen SINCLAIR PHARMACEUTICALS, LTD. BOROUGH RD. Godalming, Surrey, GB Gu7 2ab |
Product Code | MGQ |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-10-01 |
Decision Date | 2005-01-13 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00358962303005 | K042722 | 000 |