The following data is part of a premarket notification filed by Cabot Medical Corp. with the FDA for Laparoscopic Balloon Retractor.
| Device ID | K931649 |
| 510k Number | K931649 |
| Device Name: | LAPAROSCOPIC BALLOON RETRACTOR |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | CABOT MEDICAL CORP. 2021 CABOT BOULEVARD WEST Langhorne, PA 19047 |
| Contact | Todd J Polk |
| Correspondent | Todd J Polk CABOT MEDICAL CORP. 2021 CABOT BOULEVARD WEST Langhorne, PA 19047 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-05 |
| Decision Date | 1993-08-06 |