The following data is part of a premarket notification filed by Granton Medical Ltd. with the FDA for Self Seal Sterilization Pouch.
| Device ID | K023025 |
| 510k Number | K023025 |
| Device Name: | SELF SEAL STERILIZATION POUCH |
| Classification | Wrap, Sterilization |
| Applicant | GRANTON MEDICAL LTD. PO BOX 4341 Crofton, MD 21114 |
| Contact | E. J. Smith |
| Correspondent | E. J. Smith GRANTON MEDICAL LTD. PO BOX 4341 Crofton, MD 21114 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-11 |
| Decision Date | 2003-03-04 |