The following data is part of a premarket notification filed by Granton Medical Ltd. with the FDA for Granton Medical 121-135 C Self-seal Sterilization Pouches.
| Device ID | K052665 |
| 510k Number | K052665 |
| Device Name: | GRANTON MEDICAL 121-135 C SELF-SEAL STERILIZATION POUCHES |
| Classification | Wrap, Sterilization |
| Applicant | GRANTON MEDICAL LTD. 49 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Cynthia J.m. Nolte |
| Correspondent | Cynthia J.m. Nolte GRANTON MEDICAL LTD. 49 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-27 |
| Decision Date | 2006-02-27 |
| Summary: | summary |