The following data is part of a premarket notification filed by Flexbar Machine Corp. with the FDA for Retrieval Bag.
| Device ID | K123728 |
| 510k Number | K123728 |
| Device Name: | RETRIEVAL BAG |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | FLEXBAR MACHINE CORP. 30 NORTHPORT ROAD Sound Beach, NY 11789 |
| Contact | Stephen T Mlcoch |
| Correspondent | Stephen T Mlcoch FLEXBAR MACHINE CORP. 30 NORTHPORT ROAD Sound Beach, NY 11789 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-04 |
| Decision Date | 2013-12-11 |
| Summary: | summary |