The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Sarns Sternal Saw Ii, Sternal Saw Ii Blade, Sarns Saw Blades-non-sterile Bulk Pack.
| Device ID | K935391 |
| 510k Number | K935391 |
| Device Name: | SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PACK |
| Classification | Blade, Saw, General & Plastic Surgery, Surgical |
| Applicant | 3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor, MI 48106 |
| Contact | John W Toigo |
| Correspondent | John W Toigo 3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor, MI 48106 |
| Product Code | GFA |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-08 |
| Decision Date | 1994-02-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30817278011697 | K935391 | 000 |