The following data is part of a premarket notification filed by Med-dex Intl. with the FDA for Quick Change Montgomery Strap.
| Device ID | K893569 |
| 510k Number | K893569 |
| Device Name: | QUICK CHANGE MONTGOMERY STRAP |
| Classification | Tape And Bandage, Adhesive |
| Applicant | MED-DEX INTL. SUITE #237 4790 IRVINE BLVD. #105 Irvine, CA 92714 |
| Contact | Diane Momda-madison |
| Correspondent | Diane Momda-madison MED-DEX INTL. SUITE #237 4790 IRVINE BLVD. #105 Irvine, CA 92714 |
| Product Code | KGX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-09 |
| Decision Date | 1989-09-25 |