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 |