The following data is part of a premarket notification filed by Sloan Corp. with the FDA for Sloan Sta-dri Pant Protector.
Device ID | K945302 |
510k Number | K945302 |
Device Name: | SLOAN STA-DRI PANT PROTECTOR |
Classification | Accessory, Surgical Apparel |
Applicant | SLOAN CORP. 11033 W. MAPLE RD. Omaha, NE 68164 |
Contact | Stewart Sloan |
Correspondent | Stewart Sloan SLOAN CORP. 11033 W. MAPLE RD. Omaha, NE 68164 |
Product Code | LYU |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-08-30 |
Decision Date | 1996-03-19 |