The following data is part of a premarket notification filed by Phoenix Medical Technology, Inc. with the FDA for Phoenix Drapes With Microban.
Device ID | K890917 |
510k Number | K890917 |
Device Name: | PHOENIX DRAPES WITH MICROBAN |
Classification | Tape And Bandage, Adhesive |
Applicant | PHOENIX MEDICAL TECHNOLOGY, INC. P.O. BOX 16598 Fort Worth, TX 76162 |
Contact | Richard A Hamer |
Correspondent | Richard A Hamer PHOENIX MEDICAL TECHNOLOGY, INC. P.O. BOX 16598 Fort Worth, TX 76162 |
Product Code | KGX |
CFR Regulation Number | 880.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-02-23 |
Decision Date | 1989-08-17 |