The following data is part of a premarket notification filed by International Technidyne Corp. with the FDA for Surgicutt - Bleeding Time Device.
| Device ID | K850542 |
| 510k Number | K850542 |
| Device Name: | SURGICUTT - BLEEDING TIME DEVICE |
| Classification | Device, Bleeding Time |
| Applicant | INTERNATIONAL TECHNIDYNE CORP. 23 NEVSKY ST. Edison, NJ 08820 |
| Contact | Michael D Mintz |
| Correspondent | Michael D Mintz INTERNATIONAL TECHNIDYNE CORP. 23 NEVSKY ST. Edison, NJ 08820 |
| Product Code | JCA |
| CFR Regulation Number | 864.6100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-11 |
| Decision Date | 1985-03-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20711234304157 | K850542 | 000 |