The following data is part of a premarket notification filed by Case Medical, Inc. with the FDA for Steritite Sealed Containers Model Sco4q.
| Device ID | K974638 |
| 510k Number | K974638 |
| Device Name: | STERITITE SEALED CONTAINERS MODEL SCO4Q |
| 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 | 1997-10-10 |
| Decision Date | 1997-12-18 |