The following data is part of a premarket notification filed by Alpha Surgical, Inc. with the FDA for Incase Extensible Bag--non-sterile.
| Device ID | K951420 |
| 510k Number | K951420 |
| Device Name: | INCASE EXTENSIBLE BAG--NON-STERILE |
| Classification | Accessory, Surgical Apparel |
| Applicant | ALPHA SURGICAL, INC. 6132 ANDREW DR. Eau Claire, WI 54701 |
| Contact | Timothy J Juntunen |
| Correspondent | Timothy J Juntunen ALPHA SURGICAL, INC. 6132 ANDREW DR. Eau Claire, WI 54701 |
| Product Code | LYU |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-27 |
| Decision Date | 1995-06-08 |