The following data is part of a premarket notification filed by Global Healthcare, Inc. with the FDA for Global Healthcare Self-sealing Sterilization Pouch.
| Device ID | K990567 |
| 510k Number | K990567 |
| Device Name: | GLOBAL HEALTHCARE SELF-SEALING STERILIZATION POUCH |
| Classification | Wrap, Sterilization |
| Applicant | GLOBAL HEALTHCARE, INC. 130 BRANTLEY RD. Atlanta, GA 30350 |
| Contact | Alam Ahmed |
| Correspondent | Alam Ahmed GLOBAL HEALTHCARE, INC. 130 BRANTLEY RD. Atlanta, GA 30350 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-23 |
| Decision Date | 1999-04-05 |