The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Softtouch Ii Lancet Device.
| Device ID | K931258 |
| 510k Number | K931258 |
| Device Name: | SOFTTOUCH II LANCET DEVICE |
| Classification | Lancet, Blood |
| Applicant | BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Contact | Cynthia A Spain |
| Correspondent | Cynthia A Spain BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Product Code | FMK |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-12 |
| Decision Date | 1994-02-10 |