The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Micro Endoscopic Electrode (me2).
| Device ID | K931281 |
| 510k Number | K931281 |
| Device Name: | MICRO ENDOSCOPIC ELECTRODE (ME2) |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
| Contact | Azin Parhizgar |
| Correspondent | Azin Parhizgar Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-09 |
| Decision Date | 1993-07-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886704042761 | K931281 | 000 |