The following data is part of a premarket notification filed by Astro Office Products, Inc. with the FDA for Paper Film.
Device ID | K940664 |
510k Number | K940664 |
Device Name: | PAPER FILM |
Classification | System, Image Processing, Radiological |
Applicant | ASTRO OFFICE PRODUCTS, INC. 110 W. WALNUT ST. P.O. BOX 47044 Gardena, CA 90248 |
Contact | Ollie Hatch |
Correspondent | Ollie Hatch ASTRO OFFICE PRODUCTS, INC. 110 W. WALNUT ST. P.O. BOX 47044 Gardena, CA 90248 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-02-18 |
Decision Date | 1994-11-15 |