The following data is part of a premarket notification filed by Case Medical, Inc. with the FDA for Steritite Perforated Bottom Rigid Reusable Sterilization Container System With Scf02 - Polypropylene Non-woven Disposabl.
Device ID | K991023 |
510k Number | K991023 |
Device Name: | STERITITE PERFORATED BOTTOM RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02 - POLYPROPYLENE NON-WOVEN DISPOSABL |
Classification | Wrap, Sterilization |
Applicant | CASE MEDICAL, INC. 1900 K STREET, N.W. Washington, DC 20006 -1108 |
Contact | Larry R Pilot |
Correspondent | Tania Lupu CASE MEDICAL, INC. 1900 K STREET, N.W. Washington, DC 20006 -1108 |
Product Code | FRG |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-03-29 |
Decision Date | 2000-01-27 |
Summary: | summary |