The following data is part of a premarket notification filed by U.s. Mfg. & Management, Inc. with the FDA for Fluid Sampling Pack.
Device ID | K874436 |
510k Number | K874436 |
Device Name: | FLUID SAMPLING PACK |
Classification | Supplies, Blood-bank |
Applicant | U.S. MFG. & MANAGEMENT, INC. 287 SOUTH STODDARD AVE. San Bernardino, CA 92401 |
Contact | Frank J Rauscher |
Correspondent | Frank J Rauscher U.S. MFG. & MANAGEMENT, INC. 287 SOUTH STODDARD AVE. San Bernardino, CA 92401 |
Product Code | KSS |
CFR Regulation Number | 864.9050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-10-28 |
Decision Date | 1988-01-05 |