The following data is part of a premarket notification filed by S-e Sales & Distribution, Inc. with the FDA for Disposable Wound Measure Guide, Plastic, Protector, Wound, Plastic.
| Device ID | K951064 |
| 510k Number | K951064 |
| Device Name: | DISPOSABLE WOUND MEASURE GUIDE, PLASTIC, PROTECTOR, WOUND, PLASTIC |
| Classification | Tape, Measuring, Rulers And Calipers |
| Applicant | S-E SALES & DISTRIBUTION, INC. P.O. BOX 131 Poultney, VT 05764 -0131 |
| Contact | Richard J Frank |
| Correspondent | Richard J Frank S-E SALES & DISTRIBUTION, INC. P.O. BOX 131 Poultney, VT 05764 -0131 |
| Product Code | FTY |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-08 |
| Decision Date | 1995-05-19 |