The following data is part of a premarket notification filed by Blackstone Medical, Inc. with the FDA for Blackstone Medical, Inc. Laparoscopic Disc Removal System.
| Device ID | K972768 |
| 510k Number | K972768 |
| Device Name: | BLACKSTONE MEDICAL, INC. LAPAROSCOPIC DISC REMOVAL SYSTEM |
| Classification | Arthroscope |
| Applicant | BLACKSTONE MEDICAL, INC. 90 BROOKDALE DR. Springfield, MA 01104 |
| Contact | Joseph S Mooney |
| Correspondent | Joseph S Mooney BLACKSTONE MEDICAL, INC. 90 BROOKDALE DR. Springfield, MA 01104 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-24 |
| Decision Date | 1997-09-25 |
| Summary: | summary |