The following data is part of a premarket notification filed by Wescor, Inc. with the FDA for Wescor Stain Concentrate For Model 7100 Aerospray.
Device ID | K880544 |
510k Number | K880544 |
Device Name: | WESCOR STAIN CONCENTRATE FOR MODEL 7100 AEROSPRAY |
Classification | Romanowsky Stains |
Applicant | WESCOR, INC. 459 SOUTH MAIN Logan, UT 84321 |
Contact | Wayne K Barlow |
Correspondent | Wayne K Barlow WESCOR, INC. 459 SOUTH MAIN Logan, UT 84321 |
Product Code | GJL |
CFR Regulation Number | 864.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-02-09 |
Decision Date | 1988-04-01 |