The following data is part of a premarket notification filed by Dale Medical Products, Inc. with the FDA for Dale Venipuncture Tourniquet, Product No. 1335.
| Device ID | K864897 |
| 510k Number | K864897 |
| Device Name: | DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335 |
| Classification | Tourniquet, Nonpneumatic |
| Applicant | DALE MEDICAL PRODUCTS, INC. 7 CROSS ST. P.O. BOX 1556 Plainville, MA 02762 |
| Contact | Daniel W Mcelaney |
| Correspondent | Daniel W Mcelaney DALE MEDICAL PRODUCTS, INC. 7 CROSS ST. P.O. BOX 1556 Plainville, MA 02762 |
| Product Code | GAX |
| CFR Regulation Number | 878.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-15 |
| Decision Date | 1987-01-12 |