The following data is part of a premarket notification filed by Agency For Medical Innovations, Inc. with the FDA for Tissuebag, Models: A10 211, A10 212, Tbi 100, Tbi1011, Tbi1021.
| Device ID | K092821 |
| 510k Number | K092821 |
| Device Name: | TISSUEBAG, MODELS: A10 211, A10 212, TBI 100, TBI1011, TBI1021 |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | AGENCY FOR MEDICAL INNOVATIONS, INC. 20 MAIN ST., SUITE 205 Natick, MA 01760 |
| Contact | Andrew Bendheim |
| Correspondent | Andrew Bendheim AGENCY FOR MEDICAL INNOVATIONS, INC. 20 MAIN ST., SUITE 205 Natick, MA 01760 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-14 |
| Decision Date | 2010-02-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EAMITBI10310 | K092821 | 000 |
| EAMITBI10210 | K092821 | 000 |
| EAMITBI10110 | K092821 | 000 |
| EAMITBI1000 | K092821 | 000 |
| EAMIA102120 | K092821 | 000 |
| EAMIA102110 | K092821 | 000 |