The following data is part of a premarket notification filed by New England Surgical Instrument Corp. with the FDA for Electrosurgical Coagulation Suction Tube.
| Device ID | K895337 |
| 510k Number | K895337 |
| Device Name: | ELECTROSURGICAL COAGULATION SUCTION TUBE |
| Classification | Apparatus, Electrosurgical |
| Applicant | NEW ENGLAND SURGICAL INSTRUMENT CORP. P.O. BOX 35 83 EAST WATER STREET Rockland, MA 02370 |
| Contact | Richard Beane |
| Correspondent | Richard Beane NEW ENGLAND SURGICAL INSTRUMENT CORP. P.O. BOX 35 83 EAST WATER STREET Rockland, MA 02370 |
| Product Code | HAM |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-30 |
| Decision Date | 1989-09-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20841019110236 | K895337 | 000 |
| 20841019110076 | K895337 | 000 |
| 20841019108141 | K895337 | 000 |
| 00841019108086 | K895337 | 000 |
| 00841019107423 | K895337 | 000 |
| 00841019107416 | K895337 | 000 |
| 20841019107403 | K895337 | 000 |
| 20841019107397 | K895337 | 000 |
| 00841019107386 | K895337 | 000 |