The following data is part of a premarket notification filed by Ahlstrom Nonwovens Llc with the FDA for Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap.
| Device ID | K160755 |
| 510k Number | K160755 |
| Device Name: | Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap |
| Classification | Wrap, Sterilization |
| Applicant | AHLSTROM NONWOVENS LLC 2 ELM STREET Windsor Locks, CT 06096 |
| Contact | Gary Jackson |
| Correspondent | Lauren Chrapowitzky AJW TECHNOLOGY CONSULTANTS, INC 445 APOLLO BEACH BLVD Apollo Beach, FL 33572 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-18 |
| Decision Date | 2016-07-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889950110505 | K160755 | 000 |
| 00849771047322 | K160755 | 000 |
| 00849771047315 | K160755 | 000 |
| 00849771047292 | K160755 | 000 |
| 00849771047285 | K160755 | 000 |
| 00849771047278 | K160755 | 000 |
| 00849771047261 | K160755 | 000 |
| 00849771047162 | K160755 | 000 |
| 00849771047155 | K160755 | 000 |
| 00849771047148 | K160755 | 000 |
| 00849771047131 | K160755 | 000 |
| 00849771047124 | K160755 | 000 |
| 00849771047117 | K160755 | 000 |
| 00849771047100 | K160755 | 000 |
| 00849771047094 | K160755 | 000 |
| 00849771047339 | K160755 | 000 |
| 00849771047346 | K160755 | 000 |
| 10889950110499 | K160755 | 000 |
| 10889950110482 | K160755 | 000 |
| 10889950110475 | K160755 | 000 |
| 10889950110468 | K160755 | 000 |
| 10889950110451 | K160755 | 000 |
| 00849771047414 | K160755 | 000 |
| 00849771047407 | K160755 | 000 |
| 00849771047384 | K160755 | 000 |
| 00849771047377 | K160755 | 000 |
| 00849771047360 | K160755 | 000 |
| 00849771047353 | K160755 | 000 |
| 00849771047308 | K160755 | 000 |
| 00849771047506 | K160755 | 000 |
| 00849771047391 | K160755 | 000 |
| 00849771047087 | K160755 | 000 |