The following data is part of a premarket notification filed by New England Surgical Instrument Corp. with the FDA for Cranio Blades And Wire Pass Drill.
| Device ID | K861876 |
| 510k Number | K861876 |
| Device Name: | CRANIO BLADES AND WIRE PASS DRILL |
| Classification | Blade, Saw, General & Plastic Surgery, Surgical |
| Applicant | NEW ENGLAND SURGICAL INSTRUMENT CORP. P.O. BOX 35 83 EAST WATER STREET Rockland, MA 02370 |
| Contact | Kathleen M Feeney |
| Correspondent | Kathleen M Feeney NEW ENGLAND SURGICAL INSTRUMENT CORP. P.O. BOX 35 83 EAST WATER STREET Rockland, MA 02370 |
| Product Code | GFA |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-15 |
| Decision Date | 1986-05-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841019107710 | K861876 | 000 |
| 10841019107703 | K861876 | 000 |
| 10841019107697 | K861876 | 000 |