The following data is part of a premarket notification filed by Lyle Howard Corp. with the FDA for Geister Surgical Int'l Monopolar Endoscopic Surg.inst..
| Device ID | K933300 |
| 510k Number | K933300 |
| Device Name: | GEISTER SURGICAL INT'L MONOPOLAR ENDOSCOPIC SURG.INST. |
| Classification | Coagulator-cutter, Endoscopic, Unipolar (and Accessories) |
| Applicant | LYLE HOWARD CORP. ROUND VALLEY PLAZA SUITE 304 Lebanon, NJ 08833 |
| Contact | Lynette Howard |
| Correspondent | Lynette Howard LYLE HOWARD CORP. ROUND VALLEY PLAZA SUITE 304 Lebanon, NJ 08833 |
| Product Code | KNF |
| CFR Regulation Number | 884.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-07 |
| Decision Date | 1994-09-30 |