The following data is part of a premarket notification filed by Mayaguez Medical Center with the FDA for Endoscopic Blunt Dissecting Instrument.
| Device ID | K931854 |
| 510k Number | K931854 |
| Device Name: | ENDOSCOPIC BLUNT DISSECTING INSTRUMENT |
| Classification | Carrier, Sponge, Endoscopic |
| Applicant | MAYAGUEZ MEDICAL CENTER 18 CRESTWOOD DR. Trophy Club, TX 76262 |
| Contact | John Mayall |
| Correspondent | John Mayall MAYAGUEZ MEDICAL CENTER 18 CRESTWOOD DR. Trophy Club, TX 76262 |
| Product Code | FGS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-13 |
| Decision Date | 1993-08-10 |