The following data is part of a premarket notification filed by Pacific Biosystems, Inc. with the FDA for Delta Scrub.
Device ID | K872823 |
510k Number | K872823 |
Device Name: | DELTA SCRUB |
Classification | Brush, Scrub, Operating-room |
Applicant | PACIFIC BIOSYSTEMS, INC. 3440 EAST BROADWAY RD. Phoenix, AZ 85040 |
Contact | Robert P Lobban |
Correspondent | Robert P Lobban PACIFIC BIOSYSTEMS, INC. 3440 EAST BROADWAY RD. Phoenix, AZ 85040 |
Product Code | GEC |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-16 |
Decision Date | 1988-01-07 |