The following data is part of a premarket notification filed by Gs Medical Packaging, Inc. with the FDA for Sterilucent Self-seal Sterilization Pouch.
| Device ID | K141412 |
| 510k Number | K141412 |
| Device Name: | STERILUCENT SELF-SEAL STERILIZATION POUCH |
| Classification | Wrap, Sterilization |
| Applicant | GS MEDICAL PACKAGING, INC. 1400 MARSHALL ST. NE Minneapolis, MN 55413 |
| Contact | Peter Kalkbrenner |
| Correspondent | Peter Kalkbrenner GS MEDICAL PACKAGING, INC. 1400 MARSHALL ST. NE Minneapolis, MN 55413 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-29 |
| Decision Date | 2014-12-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D8305610152 | K141412 | 000 |
| D8305506752 | K141412 | 000 |
| D8305508132 | K141412 | 000 |
| D8305513230 | K141412 | 000 |
| D8305518240 | K141412 | 000 |
| D8305604092 | K141412 | 000 |
| D8305605152 | K141412 | 000 |
| D8305606132 | K141412 | 000 |
| D8305607132 | K141412 | 000 |
| D8305608162 | K141412 | 000 |
| D8305506122 | K141412 | 000 |