The following data is part of a premarket notification filed by New England Surgical Instrument Corp. with the FDA for Handswitching Monopolar Pencil.
| Device ID | K883396 |
| 510k Number | K883396 |
| Device Name: | HANDSWITCHING MONOPOLAR PENCIL |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | NEW ENGLAND SURGICAL INSTRUMENT CORP. P.O. BOX 35 83 EAST WATER STREET Rockland, MA 02370 |
| Contact | Richard M Beane |
| Correspondent | Richard M Beane NEW ENGLAND SURGICAL INSTRUMENT CORP. P.O. BOX 35 83 EAST WATER STREET Rockland, MA 02370 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-11 |
| Decision Date | 1988-09-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841019107379 | K883396 | 000 |