The following data is part of a premarket notification filed by Advanced Medical Solutions (plymouth) Ltd with the FDA for Barle Tissue Adhesive.
| Device ID | K123133 |
| 510k Number | K123133 |
| Device Name: | BARLE TISSUE ADHESIVE |
| Classification | Tissue Adhesive For The Topical Approximation Of Skin |
| Applicant | ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD WESTERN WOOD WAY LANAGAGE SCIENCE PARK Plymouth, GB Pl7 5bg |
| Contact | Michael Browne |
| Correspondent | Michael Browne ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD WESTERN WOOD WAY LANAGAGE SCIENCE PARK Plymouth, GB Pl7 5bg |
| Product Code | MPN |
| CFR Regulation Number | 878.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-04 |
| Decision Date | 2013-05-22 |
| Summary: | summary |