The following data is part of a premarket notification filed by Advanced Medical Solutions (plymouth) Ltd with the FDA for Barle Tissue Adhesive 2.
| Device ID | K132243 |
| 510k Number | K132243 |
| Device Name: | BARLE TISSUE ADHESIVE 2 |
| Classification | Tissue Adhesive For The Topical Approximation Of Skin |
| Applicant | ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD WESTERN WOOD WAY LANGAGE SCIENCE PARK Plymouth, Devon, GB Pl7 5bg |
| Contact | Kay Mcgrath |
| Correspondent | Kay Mcgrath ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD WESTERN WOOD WAY LANGAGE SCIENCE PARK Plymouth, Devon, 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 | 2013-07-18 |
| Decision Date | 2013-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05036912001090 | K132243 | 000 |
| 40884389953045 | K132243 | 000 |
| 10813799005067 | K132243 | 000 |
| 10813799005098 | K132243 | 000 |
| 10813799005128 | K132243 | 000 |
| 10813799005159 | K132243 | 000 |
| 10813799005180 | K132243 | 000 |
| 10813799005425 | K132243 | 000 |
| 00897392000240 | K132243 | 000 |
| 00897392002213 | K132243 | 000 |
| 00897392002237 | K132243 | 000 |
| 00897392002244 | K132243 | 000 |
| 40612479232271 | K132243 | 000 |
| 05036912001755 | K132243 | 000 |